FDA 483 - Claremore Compounding Center, Inc. - January 24, 2020

The FDA Form 483 details observations from an inspection, citing multiple deficiencies in drug product manufacturing. The facility used a non-pharmaceutical grade component, specifically orange food color, in drug products such as hydrocodone/dextromethorphan 10mg/10mg capsules (Lot #95806, 12/10/19) and 5mg/5mg capsules (Lot #94010, 9/11/19).

A significant quality system issue is the absence of a written stability testing program to determine Beyond Use Dates (BUD)/expiration dates for drug products. Examples include Dry Skin Moisturizing (OTC) 5% - 1% Cream (Lot #95371, 11/20/19) assigned a 360-day BUD, and CCC Cold Max and CCC Cough PE suspensions (Lots #94404 and #94402, 10/1/19) assigned 180-day BUDs. Jungle Juice Liquid (Lots #92698, #93496, #94749) also received a 360-day BUD without a stability program.

Furthermore, the firm does not conduct routine potency testing for all drug products prior to release, failing to ensure conformance to final specifications and identity/strength of active ingredients. This