Drug GMP Report

The FDA is implementing a new strategy to handle rising imports and an increasingly complex global supply chain, and it plans to begin partnering with its foreign counterparts over the next year, an agency report says.

CHICAGO — A recent trend of increasing FDA inspections and warning letters is continuing this year, as the agency has already issued 874 letters in fiscal 2011, compared with 673 last year, an FDA official says.

GlaxoSmithKline (GSK) has agreed to pay a total of $40.75 million to 37 states and the District of Columbia to address allegations of substandard drug manufacturing processes at its former manufacturing facility in Cidra, Puerto Rico.

China’s State Food and Drug Administration (SFDA) has ordered a recall of GlaxoSmithKline’s (GSK) antibiotic Augmentin after tests showed the product contained traces of a plastics additive.

Flu vaccine maker CSL Biotherapies has received an FDA warning letter for “significant objectionable conditions” at its Melbourne, Australia, facility following an untitled letter last year for GMP deviations.

After receiving a lengthy Form 483 with observations related to quality control, employee training, product testing and equipment issues, hair restoration product manufacturer Regrowth has suspended its operations.

Fresenius Medical Care’s written records of batch failure investigations do not always include conclusions and follow-up information, a Form 483 says.

In a recent Form 483 handed to Irvine, Calif.-based Stason Pharmaceuticals, the FDA makes seven observations, including calling the company’s investigations into batch noncomformances “inadequate.”

The FDA has warned active pharmaceutical ingredient (API) manufacturer ChemPacific for GMP deviations, with citations related to documentation and written procedures.

U.S. demand for functional excipients is expected to reach almost $2 billion by 2015, driven by generic competition and potential anti-counterfeiting uses.

U.S. and European pharma companies “are misinformed about the identity of manufacturers involved in all or part of the supply chain of 39 percent of drug substances they purchase from China,” an industry expert says.

Johnson & Johnson (J&J) is recalling one lot of Risperdal tablets, and one lot of risperidone 2 mg tablets marketed by Patriot Pharmaceuticals, due to uncharacteristic odor thought to be caused by trace amounts of TBA (2,4, 6- tribromoanisole).

The FDA has warned Impax Laboratories for manufacturing violations related to finished pharmaceuticals after agency inspection findings prompted the company’s March recall of fenofibrate capsules.

The FDA has filed a consent decree against OTC product manufacturer H&P Industries, its distributor the Triad Group and three individuals following bacterial contamination of H&P products.

Continuing recent efforts to closely monitor OTC product manufacturers, the FDA recently posted several warning letters sent to companies whose marketing claims would classify their products as drugs under agency regulations, or whose products contain undeclared active pharmaceutical ingredients.

The FDA has warned a Dr. Reddy’s active pharmaceutical ingredient (API) manufacturing site in Mexico for failures related to its cleaning validation and analytical methods validation.

In a recent closeout letter, the FDA told Bristol-Myers Squibb (BMS) that the corrective actions BMS has taken at its Manati, Puerto Rico, facility “sufficiently addressed” concerns raised in an August 2010 warning letter, paving the way for the June 15 approval of BMS’ kidney transplant drug Nulojix.