The GMP Letter

FDA Commissioner Margaret Hamburg is tapping a former Johnson & Johnson (J&J) executive as the new deputy commissioner within the Office of the Commissioner (OC) to oversee the agency’s device and drug centers

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.

Manufacturers of mobile medical applications (apps) that may be devices should follow the quality systems regulations, including current good manufacturing practices, when designing and developing these products, an FDA draft guidance says.

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

The medical device industry will have to wait a bit longer for regulations on the unique device identifier (UDI) database and electronic medical device reports (eMDRs).

Winston Salem, N.C.-based Cook Endoscopy recently received an FDA Form 483 for failing to determine if recalled devices are permanently removed from the market.

An extensive Form 483 handed to Xoran Technologies notes the computed tomography (CT) company did not immediately report several accidental radiation incidents to CDRH.

A Maquet Cardiovascular corrective and preventive action (CAPA) failed to follow two of the company’s procedures, according to an FDA Form 483.

Zoll Medical’s claim to be the only medical defibrillator company that hasn’t received an FDA warning letter “no longer exists,” the company said.

Applied Medical Technology, a developer and manufacturer of feeding tubes, has been cited for various cGMP violations, including investigation failures and failure to review, evaluate and perform revalidation, according to a recent FDA warning letter.

Aerscher Diagnostics received a June 28 FDA warning letter citing numerous cGMP violations, including corrective and preventive action (CAPA) violations and a failure to document acceptance activities.

The FDA has warned Peace Medical for several GMP issues, including failure to provide design control procedures, and for marketing its devices without approval or agency consent.

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

The FDA has warned Signal Medical for a series of quality system (QS) violations, including issues with its nonconforming product procedures, and is asking it for “certification by an outside expert.”