FDA 483 - McGuff Compounding Pharmacy Services, Inc. - December 31, 2014

An FDA inspection conducted between December 15 and December 31, 2014, at McGuff Compounding Pharmacy Services, Inc. in Santa Ana, CA, resulted in a Form FDA 483 listing two significant observations. The firm, a producer of sterile drug products, was cited for deficiencies related to essential quality control measures.The first observation noted that each batch of sterile and pyrogen-free drug product was not adequately tested. Specifically, the company failed to perform suitability testing on various drug formulations to ensure they didn't interfere with sterility tests. Additionally, inhibition/enhancement testing was not conducted to validate the Limulus Amebocyte Lysate (LAL) test for pyrogen detection. These omissions compromise the assurance of product safety and efficacy.The second observation highlighted the absence of a written program to assess drug product stability. The firm lacked data to support the potency of drug products throughout their labeled shelf life. Furthermore, studies were not performed on preserved multi-dose vials to confirm preservative effectiveness over time, nor were end-of-shelf-life sterility tests or container closure integrity studies conducted to ensure product sterility until expiration.These observations indicate a failure to adhere to critical manufacturing standards for sterile drug products, which are crucial for patient safety. McGuff Compounding Pharmacy Services, Inc. is required to address these findings by submitting a detailed response outlining corrective and preventive actions to bring its operations into compliance.