Drug GMP Report

In a letter May 20 to Commissioner Margaret Hamburg, Chairman of the House Committee on Oversight and Government Reform Rep. Darrell Issa (R-Calif.) criticizes the agency’s oversight of McNeil Consumer Healthcare, and cites “great difficulty” in arranging a meeting with FDA officials.

Although efforts to curb cargo and warehouse theft of pharmaceuticals have paid off, greater vigilance is necessary to ensure the security of drugs, the FDA and industry experts say.

Johnson & Johnson’s (J&J) ongoing troubles with 2,4,6- tribromoanisole (TBA), a byproduct of chemically treated wood pallets, have led to another recall — this time of HIV drug Prezista.

The FDA recently handed Spanish active pharmaceutical ingredient (API) manufacturer Moehs Cantabra, S.L. a warning letter for cGMP deviations, including a failure to document and investigate out-of-specification (OOS) results.

The FDA has given Chaska, Minn.-based Apex International a Form 483 with observations related to stability testing, testing programs and building conditions.

Woodbine, Iowa-based Apotheca Inc. was recently handed an FDA Form 483 for a repeat observation that the company did not extend an investigation into a specific drug failure to other products that may have been affected.

Active pharmaceutical ingredient (API) manufacturer BASF was handed an FDA form 483 for observations related to cleaning procedures, test equipment calibration and document adherence.

The FDA has launched a searchable database that catalogs its inspections as part of the agency’s ongoing efforts to improve transparency.

Canadian generic-drug maker Apotex has received a closeout letter from the FDA, lifting an import alert for Apotex’s Etobicoke, Ontario facility, and paving the way for Apotex to resume exports to the U.S.

Although the European Medicines Agency (EMA) last month lifted a ban due to manufacturing issues on some of its products, the FDA has handed Stockholm-based Octapharma a warning letter for cGMP violations.

In a warning letter recently handed to Cephazone Pharma for cGMP violations, the FDA acknowledges a number of written responses from the company, but says that because they weren’t received within the required time frame, the agency did not consider them before issuing the letter.

Australia’s Therapeutic Goods Administration (TGA) has published guidance to overseas drugmakers on the acceptable forms of good GMP compliance evidence and how to submit the evidence to the TGA for assessment.

Bristol-Myers Squibb (BMS) recently announced that it is recalling one lot of 1,000-count Crystalline 5mg tablets of its anticoagulant Coumadin (warfarin sodium), due to a possible potency issue discovered after a return.

In addition to citing cGMP violations, a warning letter to distribution company Golden State Medical Supply (GSMS) notes the FDA did not consider GSMS’s Form 483 response because the agency received it more than 15 business days after the 483 was issued.

The FDA has warned Indian generic company Aurobindo Pharma for GMP violations and is requesting a detailed action plan for improving packaging and labeling compliance.

The FDA has issued a warning about “hidden ingredients that can cause serious harm” in counterfeit versions of the male sexual enhancement supplement ExtenZe.

The FDA has issued a warning about illegal products currently being marketed to the Hispanic community that are labeled as dietary supplements while also claiming to be antimicrobials.