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Spectral data was also not saved automatically by the spectroscopy instrument, and the firm’s quality control unit did not review the audit trails of the generated analytical data used to clear incoming raw materials. Read More
The FDA issued a warning to Pfizer subsidiary Hospira Healthcare India for contamination risks, out-of-specification batches and other violations observed at its Chennai, Tamil Nadu facility. Read More
The FDA slapped drug manufacturer Gordon Laboratories with an eight-observation Form 483, calling the company out for testing and other violations at its Carson, California facility. Read More
Teva subsidiary Actavis Pharmaceuticals drew a warning letter from the FDA for laser-drilled tablet manufacturing at its Davie, Florida facility. Read More
The facility failed to validate its cleaning process and it had no cleaning records for rooms or drug contact surfaces. The inspectors also noted that staff wore gowns that were not sterile. Read More
Fort Lauderdale contract drug manufacturer ANDAPharm drew a warning letter from the FDA for repeat cleaning deficiencies, inadequate stability protocols and other serious problems. Read More
The FDA issued its first warning letter under the Drug Supply Chain Security Act (DSCSA), hitting McKesson for violating verification requirements and allegedly shipping illegitimate product. Read More
The FDA issued a series of warning letters to three foreign and two U.S. drugmakers, faulting them for violations ranging from inadequate aseptic processing areas to use of APIs subject to an import alert. Read More
The FDA cited Kadesh International, a Garden Grove, California drug manufacturer, for serious violations observed at its facility including the lack of a quality control unit. Read More