FDA Warns Bausch + Lomb and Indian API Maker for GMP Issues
核心洞察
FDA issued a 4 September warning letter to Bausch and Lomb (搜索) citing aseptic practice violations at its Tampa, Florida site, including restricted access barrier system design flaws and inadequate environmental monitoring.
Between 2023 and 2025 the company routinely detected out-of-limits microorganisms such as Serratia marcescens and Stenotrophomonas maltophilia in ISO 5 aseptic areas without adequate corrective action.
FDA also warned Indian API maker Shoolin Pharma LLP (搜索) over insanitary conditions in Gujarat, and placed all its drugs on Import Alert after a voluntary US recall on 4 August 2026.
The US Food and Drug Administration (搜索) issued a warning letter to Bausch and Lomb (搜索) on 4 September over aseptic practice violations at its Tampa, Florida site, where the company makes contact lenses and lens care products. FDA said the company failed to conduct operations in defined areas of adequate size and did not establish separate zones to prevent contamination or mix-ups in aseptic processing areas. The company's restricted access barrier system (RABS) line had design flaws, including placement that created ergonomic challenges during transfer of sterilized components, and lacked adequate barrier protection.
Environmental monitoring procedures were also deficient. FDA said the media used in the monitoring program was insufficient to support growth of recovered contaminants, as shown by cracked media, and that between 2023 and 2025 the company routinely identified out-of-limits microorganisms in its aseptic ISO 5 areas, including gram-negative rods such as Serratia marcescens and Stenotrophomonas maltophilia, organisms often linked to water sources. Staff demonstrated inadequate aseptic practices during filling, including reaching over exposed bottles to remove jammed ones and failing to disinfect sterile supplies. FDA said the findings show the firm does not operate an effective quality system and recommended a teleconference to discuss corrective actions. The agency previously warned the company in 2002 over GMP violations in eye care products, and warned Valeant Pharmaceuticals in 2015.
A second warning letter went to API manufacturer Shoolin Pharma LLP (搜索) over poor maintenance of its Gujarat, India facility. The company makes APIs including sildenafil citrate and tadalafil as well as anticonvulsant agents on non-dedicated equipment. FDA included photographs showing unidentified residues on production area walls, improperly gowned employees, and corroded equipment surfaces near open processing lines and API packaging, with one employee observed in open-toed sandals in front of open equipment. The agency said the company could not provide evidence that testing reported on its certificates of analyses had been performed, and lacked a stability testing program. Shoolin initiated a voluntary recall of its US-distributed APIs on 4 August 2026, and FDA placed all its drugs and drug products on Import Alert.
FDA's Center for Biologics Evaluation and Research also warned clinical investigator Stephen Fallon for violations in a study evaluating the performance and usability of the INSTI HIV Self-Test (搜索). Fallon failed to obtain signed and dated informed consent forms from all subjects and did not ensure copies were given to signers; of 42 consent forms, 35 had effective consent dates recorded by the study coordinator rather than the subjects. He also revised and implemented an informed consent form without required Institutional Review Board approval, failed to maintain device shipping records, and used white-out to alter original study entries, which FDA said made it impossible to determine what was initially recorded.
Source: RAPS