FDA 483 - Elkhart Pharmacy - December 21, 2015

This FDA Form 483 documents observations from an inspection of a facility that prepares sterile drug products. The facility's aseptic processing areas were found deficient in several aspects.

Firstly, the system for cleaning and disinfecting the room and equipment to produce aseptic conditions was inadequate. Specifically, the firm does not use a sporicidal agent or sterile wipes during the sanitation of the ISO-5 Laminar Airflow Hood, located in the ISO-7 classified sterile drug preparation room. Standard Operating Procedure (SOP) number 5.003, "Room Cleaning Procedures--Cleanroom," lacks provisions for adequate use of sporicidal agents.

Secondly, protective apparel is not worn as necessary to protect drug products from contamination. The firm does not use or provide sterile hair nets, sterile face masks, sterile beard nets, sterile eyewear, sterile gowns, or sterile boot covers for employees preparing sterile drug products.

Thirdly, results of stability testing are not used in determining expiration dates. The firm sends products for stability studies to an outside contractor but does not base Beyond Use Dating (BUD) on these findings, instead using an arbitrary six-month BUD regardless of the product. SOP number 8.021.1, "Beyond Use Dating," is not specific to each sterile preparation.

Finally, aseptic processing areas are deficient regarding systems for maintaining equipment used to control aseptic conditions. The ISO-5 Laminar Airflow Hood in the sterile processing room, certified by an outside