FDA posted 6 warning letters this week. Among the ones we cover are 1 issued to a pharmaceutical company in South Korea and 1 issued to a clinical trial investigator in California.
FDA posted 6 warning letters this week. One to a device manufacturer which we cover. And 1 for seafood HACCP, 1 for food preparation, and 3 for tobacco.
The FDA posted 13 warning letters this week. A collection were from the Center for Tobacco Products. There was 1 warning letter issued to a PET firm, 1 to a device firm, and 1 to a compounding pharmacy. We cover all 3 in this post.
FDA posted 6 warning letters on the website this week. Among the group was 1 letter issued to a compounding pharmacy and 1 issued to a finished drug facility. We address both in this post.
FDA published a total of 12 warning letters this week including: 2 to compounding pharmacies, 1 to an API manufacturer, 2 to finished drug manufacturers, and 1 to a device manufacturer. This post highlights key violations and includes links to all warning letters.
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.