FDA 483 - Jungle Jim's Pharmacy - January 26, 2015

On January 26, 2015, the FDA issued a Form 483 to Jungle Jim's Pharmacy, a producer of sterile drug products located at 5440 Dixie Hwy, Fairfield, OH 45014. The inspection, conducted from January 12-14, 16, 20, 21, 26, 2015, identified three observations.

Observation 1 noted that procedures to prevent microbiological contamination of sterile drug products lacked validation of the sterilization process. Specifically, validation studies were not performed on the (b)(4) used to sterilize pellet drug products like Testosterone 100 mg. The firm lacked studies demonstrating the equipment's ability to adequately sterilize product, consistency with varying batch sizes ((b)(4) pellets), and documentation for (b)(4) of the (b)(4). Additionally, (b)(4) used to assess (b)(4) did not accurately reflect sterilization conditions as they had a (b)(4) medium while pellet products had an air medium.

Observation 2 stated there was no written testing program to assess drug product stability characteristics. The firm lacked a program to set expiration dates, monitor stability of market batches, or assess aseptic processing control. No data was provided to support the 6-month expiration dates for drug pellet products regarding long-term sterility and potency.

Observation 3 identified deficiencies in aseptic processing