Drugs

Quality Control, Microbial Risks Flagged at API Manufacturer

FDA has identified multiple manufacturing and laboratory control deficiencies at Alps Pharmaceutical, following an inspection of the company’s facility in Hida City, Japan, according to an FDA Form 483.

The inspection, conducted in October, targeted the firm’s active pharmaceutical ingredient (API) operations and documented lapses in quality control procedures and microbiological practices that could affect product integrity for drugs supplied to the United States.

Among the most significant findings, FDA investigators reported that the company failed to adhere to its own standard operating procedure requiring synchronization of laboratory instrument clocks with actual time. Inspectors observed discrepancies in high-performance liquid chromatography systems used for release testing of APIs. Two instruments showed time deviations outside the firm’s allowable range, raising concerns about the reliability and traceability of analytical data supporting batch release decisions. The affected systems were used to test products distributed to U.S. customers.

The agency also cited the microbiology laboratory for lacking fundamental written procedures governing equipment cleaning and sample labeling. During the inspection, mold and mildew were observed inside an incubator used for microbial testing of finished APIs, indicating inadequate cleaning controls. FDA noted that no formal procedure existed for maintaining such equipment.

Additionally, investigators found deficiencies in media plate labeling practices. Prepared microbiological media lacked key identifiers such as analyst initials, inoculation dates, and traceable sample information, undermining data integrity and auditability.

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