Drugs

Guangzhou Haishi Warned About CGMP Violations

A 7/20-24/15 FDA inspection at Guangzhou Haishi Biological Technology, Guangzhou, Guangdong, China, found significant violations of current good manufacturing practice for finished pharmaceuticals, according to a just-released 6/22 Warning Letter. Specific violations included:

failing to test finished batches of drug products for the identity and strength of active ingredients;
failing to conduct at least one specific identity test on a component when relying on that component supplier’s analysis; and
failing to establish adequate written procedures for production and process control designed to assure that the drug products the company manufactures have the identity, strength, quality, and purity they purport or are represented to possess.

The letter says that despite these violations and others cited in a 7/24/15 FDA-483, the company’s quality unit released multiple batches of drug products for distribution. The firm’s response that it would purchase analytical equipment and standards to conduct incoming material testing and finished product testing was inadequate because it did not commit to testing every batch of finished product before release, FDA says. Also, it says, the response did not include a risk assessment for all of the firm’s drug products within expiry that have been distributed to the U.S.

“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 concludes. “Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance.”

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

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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