FDA 483 - Rocky Mountain Apothecary DBA Rocky Mountain Pharmacy - March 13, 2018

On March 13, 2018, the FDA issued a Form 483 to Rocky Mountain Pharmacy Inc. in Bozeman, MT, following an inspection conducted from March 6-13, 2018. The firm, identified as a producer of non-sterile drug products, was cited for two observations.

Observation 1 noted that written procedures for the cleaning and maintenance of equipment and utensils used in drug product manufacturing, processing, packing, or holding were not established and followed. Specifically, cleaning procedures between different operations were found to be deficient and lacked thoroughness to ensure complete cleaning.

Observation 2 indicated that each lot of a component liable to objectionable microbiological contamination was not subjected to microbiological tests before use. Specifically, redacted water used in the formulation of emollient creams, oral suspensions, and redacted base was not tested for microbiological content by either Rocky Mountain Pharmacy Inc. or the redacted water manufacturer. The report was issued to Ms. Jennifer K. Handsaker, Head Pharmacist, by Investigator Nayan J Patel.