FDA warns US and Australian eye drop companies for GMP violations, making unapproved claims

The US Food and Drug Administration (FDA) on Tuesday reprimanded a US manufacturer and contract testing lab, BRS Analytical Services, for producing eye drops under unsanitary conditions, and an Australian company, Melcare, for making unapproved drug claims regarding their eye drops.

Recent warning letters were also issued to an over-the-counter (OTC) drug manufacturer in China and another in the US. All four letters were posted on Tuesday.

BRS Analytical Services chastised for lax controls

FDA said it found a slew of GMP violations following inspections at BRS Analytical Services, a contract testing laboratory and eye drop manufacturer in St. Louis, MO, which also manufactures ophthalmic gels and solutions. The products have since been recalled.

Investigators said that the ISO 5 area designated for aseptic compounding and filling of sterile OTC drug products was "fundamentally unsuitable for its intended use." They noted the area had gaps in the walls meant to separate it from the surrounding warehouse, including large openings between most sections of the wall and the floor. Additionally, some of these gaps contained mesh screens that appeared to be dirty.

Inspectors said BRS Analytical Services also failed to ensure a sufficient differential pressure between the ISO 5 area and the warehouse. They said that “the lack of both physical and aerodynamic segregation in your aseptic processing facility design posed an unacceptable risk to product sterility.”

According to FDA, the company did not consistently perform air monitoring during production, despite having a procedural requirement to do so. Additionally, it said the company failed to regularly review environmental monitoring data before releasing product batches.

The warning letter stated that the facility was found to be in a state of disrepair and unclean in several instances. That includes noticeable discoloration and residue on the light panels above the aseptic filling equipment during operations, chipped paint on a floor scale, and discoloration on both the sterilizer and a table.

FDA said that the company’s employees demonstrated "poor aseptic behavior," and observations revealed that operators obstructed unidirectional airflow during routine production by placing their gloved hands and hooded, masked heads directly over open sterilized bottles.Additionally, the agency said the skin surrounding the operators’ safety glasses was exposed in the ISO 5 area, and the operators were using nonsterile face masks.

The company's quality unit was ultimately held responsible for not providing adequate GMP oversight by FDA.

The company initiated a recall of the affected products after an FDA inspection on 21 April 2025. BRS has since stopped manufacturing the products.

Melcare cited for making unapproved eye drops

In another warning letter to an eye drop manufacturer, FDA cited Melcare Biomedical in Mount Cotton, Australia, for making unapproved claims about its OTC eye drops.

Investigators reviewed the company’s product labeling, including its website where its Optimel Manuka+Forte
Eye Gel and Optimel Manuka+Dry Eye Drops are available for purchase without a prescription.

Melcare Biomedical claimed on its website that both products contain medical grade Leptospermum spp honey (Manuka) associated with “significant [sic] clinical improvements in dry eye and meibomian gland dysfunction.”

However, FDA said that the products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the Federal Food, Drug and Cosmetic Act.

Inspectors said, “although you identify honey as an inactive ingredient on the product label, statements on your website show that honey is presented as an active ingredient, because it is intended to furnish pharmacological activity for the treatment of a disease or condition.”

Foshan Yiying Hygiene cited for GMP violations

FDA issued a warning letter to Foshan Yiying Products, an OTC manufacturer in Guangdong, China, for GMP violations identified during a records review. The company’s website said the company makes cooling sprays,
cleaning wipes, and alcohol pads.

FDA said the company did not conduct adequate testing on the finished products before they were shipped to the US. It also emphasized that “testing is an essential part of CGMP to ensure that the drug products you manufacture conform to all pre-determined quality attributes appropriate for their intended use. Drug products must be tested for identity and strength of the active ingredient, prior to release and distribution.”

Investigators said the company also failed to conduct stability testing and could not demonstrate that the active ingredient in its drug products could remain stable throughout its shelf life.

Additionally, the company was cited for failing to adequately test the identity of incoming components used in its drug products, and for not being able to ensure that its manufacturing processes were reproducible and controlled “to yield a product of uniform character and quality.”

FDA placed all drugs made by the company imported into the US on an import alert.

Acme United Corporations

FDA also warned OTC drugmaker Acme United Corporation, located in Shelton, CT.

Investigators said that Acme United did not properly design and control its water system to ensure its suitability for producing water used in its drug product formulations. They noted that the company repeatedly discovered and isolated the objectionable microorganism Burkholderia cepacia (B. cepacia) both in the holding tank and at the point of use. Despite regularly sanitizing its water system after recovering B. cepacia, inspectors said the company continued to detect the microorganism shortly after each sanitization cycle.

Furthermore, FDA said that the company failed to validate its production and process controls for the manufacture of drug products and did not conduct adequate qualification activities for the equipment used in manufacturing these products.

BRS, Melcare, Foshan Yiying Hygiene Products, Acme United

FDA warns US and Australian eye drop companies for GMP violations, making unapproved claims

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