Drugs

FDA Cites SGS France Life Sciences Over Bioanalytical Method Validation

FDA has cited SGS France Life Sciences following an 8/2025 inspection, identifying multiple deficiencies involving bioanalytical method validation, study documentation and adherence to standard operating procedures at the company's Saint-Benoît, France, facility. According to a just-posted three-page Form FDA 483, investigators documented four inspectional observations related to method validation and study sample activities for a redacted product or program.

The agency's primary observation stated that a chiral analytical method used in method validation lacked sufficient specificity to accurately measure low concentrations of the analyte in the presence of high concentrations of an interfering compound. FDA said a peak exceeding 20% of the lower limit of quantitation was consistently detected despite repeated efforts to identify the source of the interference, yet the method continued to be used to measure subject samples.

FDA also criticized the company's reporting practices, saying not all tested analytical sequences were disclosed in method validation and bioanalytical reports. Investigators cited multiple instances in which failed analytical runs were rejected and repeated, but the original failures, reasons for rejection and subsequent reinjections were omitted from the final reports. These included a 12/2022 method validation run with erratic internal standard signals and two 2024 study sample runs that failed because of a reconstitution error and carryover observed in a blank sample.

Additionally, investigators found that established standard operating procedures were not consistently followed. FDA said a study director overruled a technician's decision to reject a validation run that failed pre-established acceptance criteria without documenting the deviation required under the company's methodology SOP.

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