FDA 483 - Martin Avenue Pharmacy, Inc. - July 21, 2014

During a field examination, a black particle was observed in a vial of sterile injectable human drug product Bi-Mix. The facility's procedures for preventing microbiological contamination of sterile drug products lack adequate validation of the sterilization process. Deficient aseptic practices were observed during the production of Acetylcysteine (Preservative Free) 20% Inhalation Solution, including the use of non-sterile items, improper spraying techniques, and repeated touching of open vials and caps. Sterile syringes used for filling were not labeled as non-pyrogenic, and sterilizing equipment was not tested after use. The firm does not conduct media fills or have evidence that sterilizing equipment for containers, closures, and drug products is effective or validated.

Time limits for production phases are not established, with observations of open bulk product solution left exposed and unsupported hold times for unsterilized stock solutions. Batch production records lack complete information, specifically regarding visual inspections of sterile products.

Control systems to prevent contamination during aseptic processing are deficient. Sanitization practices were inadequate, with improper use of sanitizers, lack of sanitization of HEPA filter guards, and insufficient sanitization of equipment. Environmental monitoring for microbial contamination or particles in ISO 5 hoods and the Class 10,000 clean room is not conducted during production, and personnel are not monitored for microbial contamination. Dynamic smoke pattern testing has not been conducted. The Class 10,000 clean room has a sink with municipal tap water and a