It’s 483 study time, and our GMP expert has extracted the key points in this week’s featured 483 posted by the FDA. Violations ranged from failing to provide scientific reasons for invalidating OOS results to failing to prevent colored residues on equipment.
FDA posted 7 warning letters this week including 2 warning letters to Medtronic regarding non-conformance that resulted in a Class I recall of a defibrillator earlier in 2018. In addition, warning letters were issued to 1 firm in Canada and 1 firm in China. And, in the largest coordinated enforcement effort in the FDA’s history, 1,300 warning letters were issued to a single industry.
The FDA posted 13 new warning letters this week including 7 issued by the Center for Tobacco Products, 1 to a device firm, and 1 to a compounding pharmacy. Four warning letters regarding 21 websites illegally marketing unapproved and misbranded versions of opioids including tramadol. Both the device firm and pharmacy letters are covered in this post.
The FDA posted 4 warning letters this week — 2 of which were GMP letters to drug firms. One firm manufactures APIs and the other manufactures finished pharmaceuticals. This week we also saw 2 untitled letters posted from inspections in 2016 (yes, 2 years ago). We cover all 4 in this post.
The 2nd half of our dive into MHRA’s published revision to their 2015 Data Integrity Guidance. Changes are abundant when we compare the 2015 and 2018 versions. We share (in a clear table format) the final 23 updates along with our GMP expert’s conclusions.
A very busy week on the warning letter front! Six warning letters to API/pharma firms and 1 to a GLP firm for non-clinical studies. We cover all within this post.
MHRA published a revision to their 2015 Data Integrity Guidance. The 2018 revision, in general, provides more detail and granularity than the 2015 version. Several items from the 2015 version are absent from the 2018 version. However, some items are more detailed in the 2018 version. We address all within this post and identify the nature of the addition, deletion, or revision.
This week the FDA published 4 warning letters (3 to seafood companies and 1 to an API manufacturer – Les Produits Chimiques B.G.R. Inc). We cover the latter below.