4/5 October 2023
End of December 2022, the U.S. Food and Drug Administration (FDA) has published a Warning Letter dated 22 November 2022. The letter goes back to an inspection from 25 April to 09 May 2022 at a drug repackaging and relabeling facility located in Pennsylvania. The document summarizes significant deviations from Current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (APIs). It also addresses Good Distribution Practice (GDP) aspects.
The FDA says that the company did not adequately investigate customer complaints for returned APIs. In the Warning Letter, some examples are described:
The FDA points out, that it is the company's responsibility to ensure that API returned to the "inventory and redistributed has the identity, strength, quality, and purity that it is purported to have."
According to the FDA, the firm did not adequately monitor the API storage conditions:
The FDA requested the company to provide, beside others, "a comprehensive assessment of [the] storage, holding, and environmental monitoring controls."
The FDA investigators observed that repacking and relabeling operations of APIs were performed in "an uncontrolled and open environment without adequate controls to prevent mix-ups and cross-contamination": The following example is given:
The FDA points out that those operations require appropriate handling and controls to prevent cross-contamination into other drugs. Even if the company has already committed to no longer perform repacking and relabeling operations, the FDA is concerned that mix-ups or cross-contamination could have occurred in the past.
For more details, please see the complete FDA Warning Letter to MD Pharmaceutical Supply, LLC.