Drugs

GCMP Issues at Hangzhou Facecare Cosmetics

A 6/16-6/22 FDA inspection at Hangzhou Facecare Cosmetics Co., Hangzhou, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to an 11/17 Warning Letter. Specific violations cited in the letter were:

failing to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release;
failing to test samples of each component for conformity with all appropriate written specifications for identity, purity, strength, and quality; and
failing to ensure that a drug product bore an expiration date that was supported by appropriate stability testing.

The letter says the firm’s response to the inspection observations was inadequate in that it did not provide sufficient evidence that it is taking corrective actions to bring its operations into full compliance with CGMP.

“Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant … to assist your firm in meeting CGMP requirements,” the letter says. The agency also told the company that it is responsible for the quality of drugs it produces as a contract facility, regardless of any agreement in place with product owners.

FDA placed the firm on import alert 9/14.

Hangzhou was told to respond with a list of steps it has taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome