FDA Warning Letter to pharmaceutical Manufacturer in Puerto Rico

A manufacturer of pharmaceutical OTC products in Puerto Rico received a Warning Letter from the US FDA in June due to serious GMP violations. The inspection had already taken place in April 2024.

Lack of incoming goods controls

According to the FDA, the manufacturer failed to perform an identity check of each shipment of each batch of input materials, including the active ingredients used. In addition, the manufacturer relied solely on its suppliers' certificates of analysis without checking them, for example, for compliance with the specification.

The problem of pharmaceutical water

The manufacturer in Puerto Rico uses water as an ingredient in its OTC medicines. However, according to the FDA, the water system is neither sufficiently qualified nor is appropriate monitoring in place to ensure that the water is suitable for its intended use. The FDA sees this as a risk to product quality and therefore to patient safety.

Quality Assurance

The FDA further writes that the manufacturer failed to establish an adequate quality unit responsible for overseeing the manufacture of the drugs. Specifically, the FDA cites

• Lack of adequate testing of the final product
• Lack of an adequate stability program
• Failure to adequately investigate errors that occur during in-process testing (deficiencies in batch record review)
• Failure to adequately train employees in the areas of manufacturing, packaging and storage

The FDA rates the company's quality systems as inadequate overall and refers to its guideline "Quality Systems Approach to Pharmaceutical CGMP Regulations".

The FDA welcomes the fact that the company has now ceased manufacturing at this site. Should the company resume the manufacture of drug products, the FDA states that it should retain a consultant qualified under 21 CFR 211.34 to evaluate the operation and assist in meeting GMP requirements.

The original warning letter can be found on the FDA website.