Drugs

Inspection Finds CGMP Issues at Degasa

A 9/4-9/8/17 FDA inspection at Degasa S.A. De C.V., Mexico City, Mexico, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 4/18 Warning Letter. Specific violations noted in the letter were:

failing to have, for each batch of drug product, appropriate laboratory testing, as necessary, of each batch of drug product required to be free of objectionable microorganisms; and
failing to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards.

"Significant findings in this letter indicate that your quality unit is not able to fully exercise its authority and/or responsibilities,” the letter says. “Your firm must provide the quality unit with the appropriate authority, sufficient resources, and staff to carry out its responsibilities and consistently ensure drug quality.” Based on the nature of the violations found, FDA recommended that the firm engage a qualified consultant to assist it in meeting CGMP requirements.

The letter also says that many of the firm’s products are misbranded because they violate labeling requirements for multi-language labeling, fail to contain a complete statement of identity, are not labeled in accordance with Drug Facts labeling requirements, and/or failed to disclose a domestic address or telephone number through which serious adverse events may be reported.

The firm was told to respond with a list of specific steps 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

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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