FDA warns Bausch and Lomb, Indian API maker for GMP issues
The US Food and Drug Administration (FDA) recently issued warning letters to ophthalmic product maker Bausch and Lomb and an Indian active pharmaceutical ingredient (API) maker for violations of good manufacturing practice (GMP). Both companies were cited for having lax contamination controls.
Additionally, FDA recently warned a clinical investigator in Florida due to several bioresearch monitoring violations associated with a human immunodeficiency virus (HIV) study.
Bausch and Lomb warned over aseptic practices
FDA sent a warning letter to Bausch and Lomb on 4 September citing violations related to its aseptic practices at its site in Tampa, FL. The company makes contact lenses and other lens care products.
FDA previously sent a warning letter to the company in 2002 for GMP violations related to its eye care products. In 2015, the FDA issued a warning letter to Valeant Pharmaceuticals, shortly after its acquisition by Bausch and Lomb in 2013.
In the latest warning letter, FDA said the company did not conduct its operations within specifically defined areas of adequate size and failed to establish separate or defined zones necessary to prevent contamination or mix-ups in aseptic processing areas.
The company’s restricted access barrier system (RABS) line had design flaws, including its placement, which created ergonomic challenges during the transfer of sterilized components. Investigators also observed that the line lacked adequate barrier protection.
Furthermore, the company’s environmental monitoring procedures for assessing the aseptic processing area were lacking. The media utilized in the environmental monitoring program was deemed insufficient for supporting the growth of recovered contaminants, as indicated by the presence of cracked media.
These issues led to the recovery of microorganisms in its aseptic ISO areas. The agency reported that between 2023 to 2025, the company “routinely” identified microorganisms in its aseptic ISO 5 areas that were out-of-limits (OOL). The recovered microbes included gram-negative rods such as Serratia marcescens and Stenotrophomonas maltophilia. FDA noted that these organisms are often linked to water sources, indicating a possible moisture-related contamination issue.
Yet the company continued to produce products without an adequate corrective action and preventive action (CAPA) measures to address “persistent” microbiological contamination.
The company’s staff also demonstrated inadequate aseptic practices during filling operations. This includes operators reaching over exposed bottles to remove jammed ones and neglecting to disinfect sterile supplies. Additionally, the bags used to transfer sterile bottles were exposed to the ISO 7 environment prior to manipulation.
The letter states that “significant findings in this letter demonstrate that your firm does not operate an effective quality system in accordance with CGMP. In addition to the lack of effective management oversight of your production operations, we found your quality unit is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities. Executive management should immediately and comprehensively assess your company’s global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements.”
FDA recommended that the company arrange a teleconference to discuss its corrective actions.
Insanitary conditions at Shoolin
FDA issued a warning letter to API manufacturer Shoolin Pharma LLP, highlighting violations related to the poor maintenance of its facility in Gujarat, India. The company produces APIs for various medications, including erectile dysfunction drugs like sildenafil citrate and tadalafil, as well as anticonvulsant agents. FDA noted that these ingredients are produced using non-dedicated production equipment.
The warning letter included photographs of the facility's conditions, which is uncommon. The photos showed unidentified residues on production area walls, improperly gowned employees in the production area, and corroded equipment surfaces near open processing lines and API packaging.
An employee was observed wearing open-toed sandals in the production area in front of open equipment, with chemical residues and corrosion documented on the product transfer line and both the exterior and interior of the line during active production operations.
The production area had residue and stains on the walls, floor, and equipment, particularly in places where in-process materials are handled and stored. Additionally, the equipment in this area was coated with layers of residue on its inner walls and floor.
The agency also said that the company failed to provide adequate oversight of its laboratory. “When our investigator requested supporting documentation, including equipment printouts, laboratory notebooks, worksheets, and analytical data, your firm was unable to provide any evidence that the testing reported on your certificates of analyses had actually been performed.”
The company also failed to have a stability testing program to ensure that APIs were stored under appropriate storage conditions.
Lastly, the agency lambasted the company for failing to exercise its basic oversight of API production and testing operations.
On 4 August 2026, the company initiated a voluntary recall of its APIs currently distributed within the US market.
FDA placed all drugs and drug products from the company on an Import Alert.
Informed consent violations
FDA’s Center for Biologics Evaluation and Research (CBER) issued a warning letter to clinical investigator Stephen Fallon for violations of a clinical study to evaluate the performance and usability of the INSTI HIV Self-Test. Fallon worked for a testing company called Latinos Salud in Wilton Manors, FL.
Fallon failed to obtain signed and dated informed consent forms from all subjects participating in the trials and failed to ensure a copy of the consent was given to the person signing the informed consent form (ICF).
Of the 42 ICFs signed by subjects, 35 showed that the study subjects did not personally record the effective consent date. Rather, your study coordinator documented these dates on the ICFs for these study subjects. Additionally, one study subject's ICF lacked documentation of the date of consent.”
Investigators stated that Fallon revised and implemented an informed consent form without the required approval from an Institutional Review Board (IRB).
The site also failed to maintain the device shipping records, including the packing list, certificate of analysis, certification with the Toxic Substance Control Act, and the export certificate for shipping the investigational device.
There were also data integrity problems. The site used white-out to change the original entry of some of the information collected for the study. Because of this data manipulation, FDA said that “it was impossible to determine what information was initially recorded for some study subject records, and the FDA investigator was not able to evaluate the author or date of those changes.”
