Drugs

CGMP Violations in Jalco Cosmetics Inspection

A 12/11-12/13/17 FDA inspection at Jalco Cosmetics, Silverwater, NSW, Australia, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 5/18 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 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;
failing to establish written procedures for production and process control designed to assure that manufactured drug products have the identity, strength, quality, and purity they purport or are represented to possess; and
failing to establish an adequate written testing program designed to assess the stability characteristics of drug products.

The firm’s responses to the inspection observations were inadequate. FDA reminded Jalco that the agency considers contractors to be extensions of the manufacturer and that Jalco is responsible for the quality of drugs produced as a contract facility, regardless of agreements in place with product owners.

“Significant findings in this letter indicate that your quality unit is not fully exercising its authority and responsibilities,” the letter says. “Your firm must provide the quality unit with the appropriate authority and sufficient resources to carry out its responsibilities and consistently ensure drug quality.” FDA recommended that the firm contract with a qualified consultant to assist it in meeting CGMP requirements. The company was placed on an import alert 3/8.

Jalco was told to respond with a list of 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