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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
The FDA issued a warning letter to Zhejiang Tianyu Pharmaceutical for significant deviations from current good manufacturing practices (cGMP), including impurities and lax cleaning of equipment. Read More
The FDA reprimanded Jerome Stevens Pharmaceuticals in a Form 483 for inadequate validation studies and other deficiencies observed during an inspection of its Bohemia, N.Y., plant from May 25 to June 15. Read More
Repeated problems with aseptic areas landed India’s global pharmaceutical company Cipla Limited a Form 483, in addition to new quality and computer control issues. Read More
Scottsdale, Ariz.-based BioLab Sciences has received an FDA warning letter for selling human tissue products without approved Biologics License Applications and for persistent deviations from current good manufacturing practice (cGMP) practices. Read More