FDA WARNING_LETTER - MedPark Pharmacy, LLC - March 10, 2017

On March 5, 2018, the FDA issued a Warning Letter to MedPark Pharmacy, LLC, following an inspection from January 9 to March 10, 2017. The inspection revealed serious deficiencies in the production of sterile drug products, rendering them adulterated under section 501(a)(2)(A) of the FDCA due to insanitary conditions.

Observed violations included: 1. Storage of pre-sterilized container-closure components in an unclassified area after opening. 2. Exposure of the ISO 5 core (within an ISO 7 antechamber) to unclassified room air during cleaning and when not in use, as the isolator was located in an unclassified room and turned off when not in use. 3. Use of non-sterile disinfectant for cleaning the ISO 5 isolator interior. 4. Improper handling of sterile wipes, with bulk packages opened and stored in an unclassified room. 5. An operator interrupting first air flow to an open sterile product container during compounding.

Environmental samples confirmed microbial contamination, including spore-forming bacteria, in ISO 5 aseptic processing areas. The FDA acknowledged MedPark's voluntary recall of sterile compounded medications (June 1, 2017) and cessation of sterile drug compounding (March 28, 2017). However, the firm's corrective actions were deemed inadequate, lacking specific timelines for sterile