FDA Warning Letter issued to pharmaceutical Manufacturer in Puerto Rico

Max Chemical Inc., a pharmaceutical OTC product manufacturer in Puerto Rico, received a Warning Letter from the FDA in June due to significant GMP violations. The inspection took place in April 2024.

Key Issues Identified:

- Incoming Goods Control: The FDA noted that Max Chemical Inc. failed to verify the identity of each batch of input materials, including active ingredients, relying solely on suppliers' certificates of analysis without conducting necessary checks.

- Pharmaceutical Water Quality: The company's water system, used as an ingredient in OTC medicines, was not adequately qualified or monitored, posing a risk to product quality and patient safety.

- Quality Assurance Deficiencies: The FDA highlighted the absence of a robust quality unit and cited several issues, including:

  - Insufficient final product testing

  - Lack of a proper stability program

  - Inadequate investigation of in-process errors

  - Poor employee training in manufacturing, packaging, and storage

The FDA deemed the company's quality systems inadequate and recommended hiring a consultant qualified under 21 CFR 211.34 before resuming operations. The original warning letter is available on the FDA website.