We receive a lot of questions, especially from our international colleagues, about how FDA 483s are actually written – the whole “lifecycle”, if you will.
In another significant slip, inspectors found that Zorro Technology had not given employees any training in cGMPs (or at least couldn’t prove that they had).
Abbott Nutrition was cited a few years ago for failing to exclude pests from processing areas. This was the plant’s 31st citation related to warehouse
Meridian Medical Technologies was cited when inspectors saw a something “which appeared rust-like…on the bottom of the stainless steel plate located across the top of
Avoiding FDA 483s Strategy #4: Make sure written procedures for testing are rock-solid—and follow them
Wyeth was dinged by inspectors when it failed to follow its own written procedures for sampling and testing—specifically failing to test at the beginning, middle
During this August, FDA 483s month here at FDAzilla, we repost some of our favorite pieces related to 483s. Here’s another from the QA Pharm.
In a recent 483, Baxter was cited for falling short on two exception verifications. This included failing to be sure that lots placed on QA
Formulation Technology was hit with a 483 when inspectors found that testing and release of drugs made there didn’t include “appropriate laboratory determination of satisfactory
In one extreme case, an FDA inspection concluded that Zorro Technology didn’t have written quality control procedures at all, that drug ingredients weren’t identified in