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The integrity of manufacturers’ data is a major focus of FDA inspections and the agency’s investigators will go to great lengths to uncover problems, three former FDA inspection officials told attendees at the WCG FDAnews 17th Annual FDA Inspections Summit in Washington, D.C. last week. Read More
Aarkish Pharmaceuticals received a nine-observation Form 483 for missing records and other quality lapses observed during an inspection of its Fairfield, N.J., facility. Read More
The FDA issued a nine-observation Form 483 to ImprimisRx’s Ledgewood, N.J., facility for unsanitary conditions and other deficiencies observed during a July 11 to Aug. 5 inspection. Read More
Appco Pharma’s Piscataway, N.J. generic drug manufacturing facility was dinged by the FDA for lacking temperature and humidity records for some equipment and other documentation lapses listed in a five-observation Form 483 following an Aug. 8-19 inspection. Read More
The FDA scolded Jubilant Pharma for failing to properly investigate batch discrepancies and keep written records, among other deficiencies, during an inspection of its Indian facility in Sikanderpur Bhainswal, Uttaranchal conducted from July 20 to Aug. 1. Read More
On the heels of a recent FDA write-up, another Catalent facility drew a Form 483 from the agency for multiple quality lapses following an inspection of its Brussels, Belgium, plant. Read More
The FDA rapped Fresenius Kabi for batch discrepancies and contamination issues, among other quality lapses, following an inspection of its Melrose Park, Ill., facility. Read More
Eksa Mills has stopped drug manufacturing activities at its Puebla, Mexico, facility in the wake of an FDA warning letter that cites the company’s quality unit for failure to properly oversee the manufacture of drug products. Read More
Baxter Healthcare’s drug manufacturing facility in Marion, N.C., was hit with a seven-observation Form 483 citing inadequate change controls and other quality lapses following an inspection in May. Read More
Problems with capsule weights, new equipment that hadn’t been qualified and air temperature discrepancies have resulted in a three-observation FDA Form 483 for the Fenton, Mo., plant of Mumbai-based generic drugmaker Alkem Laboratories. Read More
German drug manufacturer System Kosmetik has drawn an FDA warning letter for lacking manufacturing process validation and other deficiencies observed during an FDA inspection of its facility in Bavaria in February. Read More