The QMN Weekly Bulletin

Fercy Personal Care Products, a Chinese OTC drugmaker, has been warned for a host of quality problems at its Jinhua, China, facility and for limiting investigators’ access to the unregistered plant.

Devicemakers can begin taking steps to comply with new electronic copy requirements for most types of FDA submissions, thanks to an FDA draft guidance.

A new bipartisan track and trace proposal floated by House and Senate lawmakers last week would implement a uniform national policy on drug product tracing, heading off state-by-state initiatives.

While the degree of risk and a company’s history dictate the level of regulatory scrutiny a device recall audit gets, recall strategies are expected to document supply chain communications down to the patient, FDA and Health Canada officials say.

South Jordan, Utah-based Merit Medical received a letter from the FDA stating the company has resolved all issues related to a Jan. 30 warning letter, the company said.

Ameridose is recalling all of its unexpired product as an ongoing FDA inspection of its Westborough, Mass., facility has raised sterility concerns.

St. Jude filed an Oct. 24 Form 8-K with the SEC stating the company had received a Form 483 for observations made during a Sept. 25 to Oct.

Drugmakers’ quality control checklists make it difficult for inspectors to interpret manufacturing failures and foster a true understanding of mistakes, regulators and industry officials say “Check-the-box approaches have the advantage of promoting a degree of quality consistency, but they close down the mind to a bigger picture,” Ian Thrussell, head of inspections at the World Health Organization and an expert inspector with the UK’s Medicines and Healthcare products Regulatory Agency, said.