Findings citing 21 CFR 211.56

Your firm failed to maintain the buildings used in the manufacture, processing, packing, or holding of a drug product in a clean and sanitary condition (21 CFR 211.56(a)).

Your firm failed to maintain the buildings used in the manufacture, processing, packing, or holding of a drug product in a clean and sanitary condition (21 CFR 211.56(a)).

Your firm failed to maintain the buildings used in the manufacture, processing, packing, or holding of a drug product in a clean and sanitary condition and to keep them free of infestation by rodents, birds, insects, and other vermin (21 CFR 211.56(a)). Your firm manufactures over-the-counter (OTC) topical drug products. Our investigator observed pest activity in your raw material storage area, and evidence of water leaks and missing ceiling tiles in your drug manufacturing…

Your firm failed to maintain the buildings used in the manufacture, processing, packing, or holding of a drug product in a clean and sanitary condition and to keep them free of infestation by rodents, birds, insects, and other vermin. Trash and organic waste matter shall be held and disposed of in a timely and sanitary manner. [21 CFR 211.56(a)]. Specifically, on July 14, 2023, your Quality Assurance team observed a box of food from June 16, 2023, covered in scuttle fly pupae in the mechanical room which houses the air handling units and failed to remove the box of food until July 31, 2023. After this event, scuttle fly larvae were found in ten environmental and personnel monitoring samples collected in the cleanrooms in July 2023. Additionally, on July 26, 2023, in Suite (b)(4) Clean Room (b)(4) (Grade (b)(4) ) a living scuttle fly was observed on the tube rack. Adequate control of insect infestation is needed to ensure product quality and safety.

Failure to establish and follow written procedures describing in sufficient detail the methods and materials used for sanitation [21 CFR 211.56(b)]. For example: a. Your firm failed to validate the cleaning process for your cleanrooms. b. Your firm has not adequately established and followed written procedures for cleaning the cleanrooms used to manufacture your products. For example: i. In accordance with your cleanroom cleaning procedure, a (b)(4) cleaning of all contact…

Failure to establish written procedures describing in sufficient detail the cleaning methods, equipment, and materials to be used in cleaning the buildings and facilities [21 CFR 211.56(b)]. a. You have not validated the process for cleaning and disinfecting your (b)(4) . b. At the time of the inspection, your written procedure for cleaning and disinfection of (b)(4) was inadequate in that it did not include a description in sufficient detail of the cleaning schedules, methods, equipment, and materials to be used in cleaning the facility. Specifically, the written procedure lacked adequate instructions, including cleaning agents used, contact times for disinfectants, and use of a sporicidal agent.