Drug GMP Report

Johnson & Johnson’s (J&J) ongoing manufacturing issues can largely be pinned on mistakes made during its Pfizer Consumer Healthcare (PCH) acquisition, a special J&J committee says — just as pharma execs predict a slew of M&A activity over the next two years.

FDA Commissioner Margaret Hamburg is creating two new deputy commissioner positions at the agency — one to oversee medical products and the other to guide the FDA’s global regulatory operations — as the agency beefs up its oversight of drug-device pairings and imported products.

The Pew Health Group is taking aim at FDA and industry oversight of foreign manufacturing, calling for increased agency authorities, such as the ability to mandate recalls and subpoena witnesses and documents.

The FDA is halting imports from Indian pharma giant Dr. Reddy’s Mexico facility after issuing the company a June warning letter for cGMP violations.

BBC Biochemical lacks procedures and controls to prevent microbiological contamination of product, according to an FDA Form 483 recently handed to contract manufacturer.

Fort Lauderdale, Fla.-based Watson Laboratories has received an FDA Form 483 after failing to thoroughly review any unexplained discrepancies or failures of batches.

A lengthy Form 483 recently handed to Hospira notes that “products failing to meet established quality control criteria are not rejected.”

American Regent is recalling one lot of calcium gluconate injection “due to particulates” — the latest in a string of particulate-related recalls.

The FDA has warned Polish pharmaceutical manufacturer Jelfa SA, citing “worrisome” cGMP deficiencies, including a number of repeat violations.

The European Commission (EC) is tightening supply chain guidelines, requiring pharmaceutical distributors to audit and approve transportation hubs where the products are loaded and reloaded.

The FDA is proposing to remove a controversial section of the Prescription Drug Marketing Act that requires unauthorized pharmaceutical distributors to provide drug-tracking, or “pedigree,” information during wholesale distribution.

The FDA is offering a research grant aimed to improve manufacturing speed and reliability under its Critical Path Manufacturing Sector Initiative.

The FDA has warned Indian active pharmaceutical ingredient (API) and generics maker Zydus Group, a division of Cadila Healthcare, for a number of cGMP violations, including incomplete test data.

The FDA has warned Alpha Laboratories, a contract testing laboratory, for quality violations such as approving certificates of analysis containing out-of-specification (OOS) results without an investigation.