Drugs

A.Nelson Warned on GMPs After Inspection

FDA has issued a Warning Letter to London-based drug manufacturer A. Nelson & Co. Ltd., citing significant current good manufacturing practice violations and raising concerns about microbiological testing and data integrity at the company’s facility. The 2/12 letter said an unannounced inspection conducted 9/2025 at the firm’s site in London found that the company failed to adequately test certain batches of homeopathic drug products for microbial contamination before releasing them to the U.S. market.

According to the letter, A. Nelson & Co. released multiple batches of homeopathic drug products — including products labeled for children as young as two years old — without conducting appropriate testing to ensure they were free of objectionable microorganisms. Rather than testing each batch, the company conducted limited testing on some batches and did not perform microbial testing before release for certain products, FDA said. In addition, investigators found the firm extended expiration dates on some products without sufficient stability data to support the longer shelf lives.

Of particular concern, one drug product batch was detained and refused admission at the U.S. border after FDA testing detected microbiological contamination. The agency said that without batch-by-batch microbial testing prior to release, the firm lacked scientific evidence that its products were free from objectionable contamination.

Beyond microbiological deficiencies, FDA cited serious lapses in the company’s quality control unit oversight and documentation practices. Investigators found that critical CGMP records — including manufacturing records and finished product specification forms — were improperly discarded. Among the discarded materials was a handwritten note referencing an “out-of-trend” analytical result and a quality determination that had not been properly documented or investigated.

The FDA said the company also printed duplicate copies of records without procedures to track issuance and reconciliation of CGMP documents. Analytical forms showing unacceptable results were discarded without triggering required investigations, raising “significant data integrity concerns,” it said.

Given the scope of the violations, FDA recommended that the company engage a qualified CGMP consultant to conduct a comprehensive audit and evaluate the effectiveness of remediation efforts.

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