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Company owner, frantically texting the FDA, crying in the same tone as someone who was discovered cheating because their spouse looked at their phone.
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May 22, 2023 21:38
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Discendo Vox posted:This particular report is "the facility for some reason believed it would not be inspected and had none of the documentation". Observations 5 and 6 (before you even get to the plainly visible contamination) are describing the total absence of basic required documents. Many of the observations are like that. At a guess, this firm was running the facility to either some domestic or third country spec (or just to whatever they made up) and didn't care about US regs (or thought they had bribed someone to not be inspected). So they didn't follow every requirement of our bloated bureaucracy. The FDA are a bunch of egg heads who don't understand how the business world works. Drain the swamp. -senator dilbeck
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May 22, 2023 23:22
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Discendo Vox posted:This particular report is "the facility for some reason believed it would not be inspected and had none of the documentation". Observations 5 and 6 (before you even get to the plainly visible contamination) are describing the total absence of basic required documents. Many of the observations are like that. At a guess, this firm was running the facility to either some domestic or third country spec (or just to whatever they made up) and didn't care about US regs (or thought they had bribed someone to not be inspected). Oh god, I love this one. These are my trainwreck-watching materials, definitely. Edit - So, I was going to do a laymen's summary of this one for the thread, but it's so horrible and glorious and it's loving fourteen pages of INSANE asshattery. I don't have the time to do it justice. Edit #2 - lol this is the Lab Rat thread, not the Corporate thread. You guys don't need a laymen's summary anyway.  For reference, Grade B area is not the cleanest of clean, but it's CLEAN AS gently caress. I do drastically better than this in a Grade E / ISO 8 area. Exposed nails and nail-holes would not cut it for a loving storage room, let alone aseptic filling.     Get hosed, Global Pharma Ltd. Get outright hosed for this next one. They sourced at least one API from another vendor, and then didn't check the material when they got it and relied on the vendor's documentation. You cannot do that, ever. You can't even do that for non-API materials or fillers; at bare minimum you have to do identity (prove it's the right material), and for APIs you have to do far more. I mean, get hosed for almost all of this. Someone should be in prison for the summation of these audit findings, or at bare minimum barred from ever working in a regulated environment again.  This one isn't quite clear, but it probably says [para] "You turned around manufacturing on Equipment A from one product to the next based on cleaning verification you performed on Equipment B."  That's not even getting into all the "holy gently caress, our entire facility shouldn't even count as qualified" stuff in Observation 7 or the deficient QC structures in Observations 8 & 9. Sundae fucked around with this message at 02:23 on May 23, 2023 |
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May 23, 2023 02:18
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“Your procedures claim to use Filter A for sterilization. You were unable to produce a receipt for a purchase of a single Filter A. We found cases of unused Filter F’s nearby, suggesting you (1) never used the right filter at all and (2) change the filters basically never.” The thing I love about an FDA audit is they can walk in and the facility can literally be on fire, leaking fluids into manufacturing processes, and they’ll document all that, yeah, sure, but after the first page describes the fire, subsequent paragraphs will tell you not just how much piss is on the seat in the men’s room, but also if one of the printers allows past jobs to be recalled without a login as that could be a data integrity threat. What a great agency.
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May 23, 2023 03:50
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RadioPassive posted:“Your procedures claim to use Filter A for sterilization. You were unable to produce a receipt for a purchase of a single Filter A. We found cases of unused Filter F’s nearby, suggesting you (1) never used the right filter at all and (2) change the filters basically never.” I believe it's part of the defensive litigation prep approach from the agency; once they've decided there's enough in a place to be actually actionable (with their incredibly limited resources), they want to document every violation so that the firm can't get out of it by getting some stuff thrown out for whatever reason. edit: A lot of FDA's policies make sense if you understand them as under constant threat from extremely multiple armies of well-funded attorneys who spend years building test cases to revoke as much regulatory authority as possible - either in specific product areas, or the real libertarian psychos who want to destroy the whole agency. It's a century-long siege mentality. Discendo Vox fucked around with this message at 08:51 on May 23, 2023 |
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May 23, 2023 04:19
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In the Summer of 2019 we were standing up a new drug manufacturing line. The FDA sent 5 auditors out to spend a week inspecting it. Zero Written Defects Some companies consider regulations as a restriction, we consider them a challenge.
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May 23, 2023 04:28
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mllaneza posted:In the Summer of 2019 we were standing up a new drug manufacturing line. The FDA sent 5 auditors out to spend a week inspecting it. In fairness, we've gone and poo poo ourselves a few times since then. For example, "no hot water available for operators of [redacted] to wash their hands" at multiple sites, the joys of the last three years of cleaning investigations around [redacted third-party contractor]," etc etc. Honestly, I'd expect to see more issues in the future. Our budgets are just getting hosed right now for 2023-2025, and with no backfills planned for attrition over the next 12mo+, things may very well start to slip. 
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May 23, 2023 04:44
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Sundae posted:In fairness, we've gone and poo poo ourselves a few times since then. I just hope none of that poo poo sticks to you.
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May 23, 2023 05:08
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mllaneza posted:I just hope none of that poo poo sticks to you. Don't worry - if it does, at least I made sure we have hot water and soap in our building. 
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May 23, 2023 05:40
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Discendo Vox posted:I believe it's part of the defensive litigation prep approach from the agency; once they've decided there's enough in a place to be actually actionable (with their incredibly limited resources), they want to document every violation so that the firm can't get out of it by getting some stuff thrown out for whatever reason. Yeah, paperwork is how you get things to stick. Just speaking from being audited by other organizations before they look at systems and receipts heavily alongside immediate concerns because you could have a puddle of blood in the break room and it's a problem, but it's also as far as you know a one time occurrence. But if you can be shown that you haven't been doing X for a *long* time then that is a much bigger and much more entrenced problem that is well documented (at least by lack of documents).
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May 23, 2023 13:46
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How do I get through an indefinite period of 12 hour night-shifts without drinking all the 200 proof ethanol in the fridgeSundae posted:I will continue to make dumb jokes about ramen spectroscopy is and nobody can stop me. also lol
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Jun 13, 2023 12:13
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Matryoshka SexDoll posted:How do I get through an indefinite period of 12 hour night-shifts without drinking all the 200 proof ethanol in the fridge You're on night shift just bring in regular liquor and put it in some sample vials. Who is around to question you at 2am?
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Jun 13, 2023 13:47
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Matryoshka SexDoll posted:How do I get through an indefinite period of 12 hour night-shifts without drinking all the 200 proof ethanol in the fridge I did night rotations for years. There's no way around it: they suck. I hung on by clinging to interesting work I could focus on. No management to hover over me helped. Lots of cspam too which definitely isn't healthy. Sadly, it's normal in a lot of industry that night crew roles almost expect to burn through lab nerds to an extent.
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Jun 13, 2023 14:12
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Matryoshka SexDoll posted:How do I get through an indefinite period of 12 hour night-shifts without drinking all the 200 proof ethanol in the fridge Use your slow hours to get a masters; then move on.
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Jun 13, 2023 14:33
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street doc posted:Use your slow hours to get a masters; then move on. This is a good answer.
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Jun 13, 2023 23:11
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I was starting to think I'm shadowbanned from agilent phone support. The phone tree has been broken for years for me (option 3 option 2 asks for a ticket number, wtf). So I mash buttons till I get someone and they connect me. Once connected support has still been amazing. But this round on the third call the lady was curt and unhelpful. Made me think they were cutting me off. 4th call was helpful again though, so must have just been coincidence. Still don't understand the phone tree thing though
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Jun 16, 2023 20:08
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I have two interns in my lab right now. I told one of them "label these four tubes *plasmid name* then A through D." I checked today, all four tubes were labeled "*plasmid name* A-D". Four different colonies picked into four tubes with an identical label. So that's how my weekend is kicking off. If you'll excuse me, I have an appointment with a throw pillow into which I need to scream myself hoarse. mycomancy fucked around with this message at 20:45 on Jun 16, 2023 |
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Jun 16, 2023 20:33
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The true mark of summer.
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Jun 16, 2023 21:55
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Jun 16, 2023 22:06
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I had an undergrad once who was helping me with immunostaining. I happened to glance over and see him standing at the sink, running the tissue sections under the water and squirting hand soap on them. I was so focused on the “tricky“ steps that I just mentioned the washing steps in passing. When he got to the first “wash“ step in the protocol, he decided he knew the best way to wash something...
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Jun 17, 2023 01:17
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Logged in to see if my last minute PTO request was approved* and saw an email from a collections agency on behalf of Gilson for outstanding payments. * It was. It's a Tuesday problem now.
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Jun 17, 2023 01:48
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I had a master's in biotech ask me if they needed separate pipette tips for different samples when processing blood. They lasted maybe 2 months, thank gently caress.
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Jun 17, 2023 11:37
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Johnny Truant posted:I had a master's in biotech ask me if they needed separate pipette tips for different samples when processing blood.  what is wrong with people nowadays? I feel like I can't trust anyone to do anything anymore.
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Jun 17, 2023 12:57
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It’s all red so what’s the difference??
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Jun 17, 2023 17:16
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mycomancy posted:I have two interns in my lab right now. I told one of them "label these four tubes *plasmid name* then A through D." I had a guy mark all of our hazardous waste with *example* and *put date here* on the labels once.
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Jun 18, 2023 19:49
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been out of the game five years and still yelled "Jesus Christ" out loud multiple times reading this crop of stories
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Jun 18, 2023 23:49
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Alright, my interns have been corrected and I feel much better about my life. Think I'll wait on taking any more rotrons in my lab until my postdoc arrives in October, I can't do all my work while I'm wiping grad student asses.
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Jun 19, 2023 15:53
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Douche4Sale posted:I had an undergrad once who was helping me with immunostaining. I happened to glance over and see him standing at the sink, running the tissue sections under the water and squirting hand soap on them. he's just permeabilizing for you in a cheaper way.
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Jun 22, 2023 04:00
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Repeating an old experiment for a user now and our values fluctuate a lot creating very noisy data compared to the last run. Turns out it is because the tubes we use for sampling are of a different brand since last time because our procurement supplier changed it, likely for cost reasons. So now the tubes vary in weight up to 30 milligrams per tube and the stated dimensions are probably also differing slightly from reality because some tubes can't fit our freeze racks which fit the old tubes of ostensibly the same dimensions 
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Jun 22, 2023 08:58
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Zudgemud posted:Repeating an old experiment for a user now and our values fluctuate a lot creating very noisy data compared to the last run. Turns out it is because the tubes we use for sampling are of a different brand since last time because our procurement supplier changed it, likely for cost reasons. So now the tubes vary in weight up to 30 milligrams per tube and the stated dimensions are probably also differing slightly from reality because some tubes can't fit our freeze racks which fit the old tubes of ostensibly the same dimensions We've been having similar fun times with culture tubes and other "store brand" plasticware. VWR branded items seem to be the most egregious offenders, particularly their electroporation cuvettes and their falcon-style culture tubes. I've had to swear off plastic completely for my thermophile work, as I kept having cultures spontaneously fail for no other discernable reason; I moved to glass culture tubes and it stopped. I suspect they're using a different chemical to release plasticware from the molding, but I don't know for sure.
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Jun 22, 2023 12:33
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Tube quality! Just a couple weeks ago had to send another break up letter to a vendor who hosed up their tube quality. Hope the new one lasts a little while.
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Jun 22, 2023 12:51
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Any opinion on falconware? I don’t believe their RNase free certification.
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Jun 22, 2023 13:57
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Buy an RNA oligo and see if it degrades in the tube.
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Jun 22, 2023 18:17
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i always figured Falcon was the NameBrand stuff made by Corning and the highest likelihood of being good, with absolutely no evidence or data to back that up. if you had problems with RNA in their stuff it's probably because you thought too hard about the RNA, and it degraded out of shame.
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Jun 23, 2023 08:42
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Johnny Truant posted:I had a master's in biotech ask me if they needed separate pipette tips for different samples when processing blood. The hospital I trained at used expensive positive displacement pipette tips to get 20/100/150 μL of patient samples into 96 well plates, since precision was a key requirement. To reduce tip waste (and costs), they implemented a protocol of rinsing the tip in 5ml tubes of MilliQ water, then methanol, then a second 5ml aliquot of MilliQ water between each sample. The rinse protocol was validated by testing the second MilliQ water with the triple-quad mass spec, and that didn't find any analyte - so apparently that worked. However, I get the feeling this story didn't feature positive displacement tips. I sure as hell wouldn't try that with an air displacement Gilson. crabrock posted:if you had problems with RNA in their stuff it's probably because you thought too hard about the RNA, and it degraded out of shame. Please, no you're giving me flashbacks to my PhD. I had to get a 1mm slice of deep-frozen cardiac atrium, move it to the phenol/chloroform and get it ready for bead beating in like 30 seconds before it thawed too much. You haul your rear end off, you try not to get cancer from the phenol/chloroform, and your RIN still looks like arse. Lunar Suite fucked around with this message at 10:46 on Jun 23, 2023 |
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Jun 23, 2023 10:41
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crabrock posted:if you had problems with RNA in their stuff it's probably because you thought too hard about the RNA, and it degraded out of shame. The RNA knows what you did and it is so sad about it that it now has to die
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Jun 23, 2023 10:52
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Lunar Suite posted:To reduce tip waste (and costs), they implemented a protocol of rinsing the tip in 5ml tubes of MilliQ water, then methanol, then a second 5ml aliquot of MilliQ water between each sample. You've got to be loving kidding me
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Jun 23, 2023 11:23
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Lunar Suite posted:The hospital I trained at used expensive positive displacement pipette tips to get 20/100/150 μL of patient samples into 96 well plates, since precision was a key requirement. To reduce tip waste (and costs), they implemented a protocol of rinsing the tip in 5ml tubes of MilliQ water, then methanol, then a second 5ml aliquot of MilliQ water between each sample. The rinse protocol was validated by testing the second MilliQ water with the triple-quad mass spec, and that didn't find any analyte - so apparently that worked. Did they have you blow on them to make sure they were dry before using them again?
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Jun 23, 2023 13:20
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Again: They ran the second water tube through the mass spec and detected nothing. The protocol was validated. I was shocked at first too, but they have evidence the method is sound, and the regulatory agencies didn't flag it on SOP review either.CuddleCryptid posted:Did they have you blow on them to make sure they were dry before using them again?
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Jun 23, 2023 13:21
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Washing pipette tips is the maddest loving thing I've heard about in a while.
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Jun 23, 2023 13:35
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