FDA Warning Letter to Drug Manufacturer in Puerto Rico

Just recently, you could read about a Warning Letter to an American manufacturer of hand sanitizer drug products. Therein, the U.S. Food and Drug Administration (FDA) once again highlights the importance of analytical testing of incoming raw materials, finished drug product testing and stability testing. In the case in question, the manufacturer had been found to have significant deficiencies in these areas.

Now another Warning Letter dated 02 November 2022 has been published by the FDA, also addressed to such products. This time it is about a drug manufacturer located in Puerto Rico.

During an inspection from 25 April to 06 May 2022, the FDA found significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. In addition to formal violations and inadequate analytical testing, the FDA also criticized the condition of the production facility. Regarding the last point, the authority writes that FDA investigators observed the facility "to be in a state of disrepair, poorly cleaned, and maintained as evidenced by insects, cobwebs, and unexplained spills in [the] manufacturing and raw material storage areas. In addition, a portion of the raw materials warehouse for drug products was exposed to the external environment."  To make matters worse, similar conditions were found during a previous inspection in 2017.

In detail, the Warning Letter then addresses the following issues:

  • Quality control unit: The company lacked adequate personnel responsible for the quality oversight. This was not disputed by the company. The Quality Manager even admitted "that he is not always present during the execution of manufacturing activities when he signs under "verified by" on manufacturing batch records."
  • Sampling and identity testing: The firm failed to perform an identity test on samples of each component lot used in the production. In addition, the company "relied on certificates of analysis (COAs) from suppliers and failed to establish the reliability of each of your suppliers' COAs for component specifications and characteristics."
  • Water system: It was not ensured that the water system was suitable for producing water used in the formulation of the drug products. There was also no evidence that the system was regularly inspected, maintained, disinfected and monitored to ensure that the minimum requirements or limits of the United States Pharmacopoeia (USP) were consistently met.

In the Warning Letter, the FDA lists a whole series of measures that the company must implement. Based upon the nature of the violations, the FDA strongly recommends engaging a consultant to assist in meeting CGMP requirements.

For more information, please see the complete Warning Letter to Omega & Delta Co., Inc., which can be accessed on the FDA's website.

Go back


Stay informed with the GMP Newsletters from ECA

GMP Newsletter

The ECA offers various free of charge GMP newsletters for which you can subscribe to according to your needs.

To subscribe, please click here.