The FDA is citing Spanish drug materials maker Bioiberica for a number of manufacturing issues, which are outlined in a Form 483. The facility, which is located in Palafalls, Spain, was inspected by ...
Cipla clarified that its supply partner Pharmathen received nine USFDA Form 483 observations during a November 2025 inspection of its Greece facility for Lanreotide Injection, and the company is ...
The FDA injected a Form 483 frown into Revance Therapeutics’ plans to gain regulatory approval for its Botox rival daxibotulinumtoxinA, citing quality control and records issues at the manufacturing ...
The FDA has released a copy of its Form 483, which outlines observed conditions at the New England Compounding Center in Framingham, Mass. The NECC is under investigation for contaminated products ...
Freedom of Information Act requests filed with the Food and Drug Administration by hedge funds last month revealed big financial players closely eyeing warning letters, enforcement documents, and ...
PolarityTE, Inc. (“PolarityTE”) is a biotechnology company headquartered in Salt Lake City, Utah that develops regenerative tissue products. 2 PolarityTE’s flagship product is a tissue product called ...
Regulatory action at Pharmathen’s main manufacturing site in Greece could potentially disrupt supplies of one of Cipla’s important complex injectables ...
Having noticed an uptick in medical device recalls and FDA warning letters to medtech companies this year, it seems an appropriate time to look back on a Form 483 from December 2016 that surprised ...
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