Cleaning validation Findings

Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)). You failed to demonstrate that your cleaning practices are adequate to remove potential contaminants and to prevent drug product carry over in shared equipment used to manufacture your OTC drug products. For example, your cleaning validation program for the non-dedicated Unit (b)(4) Line (b)(4) relied exclusively on the visual inspection of…

Failure to clean equipment to prevent contamination or carry-over of a material that would alter the quality of the intermediates and API beyond the official or other established specifications. Your firm failed to adequately clean and maintain non-dedicated API manufacturing equipment used to manufacture as many as (b)(4) different APIs. For example, our investigator observed (b)(4) and (b)(4) particles on product contact surfaces, including the lid and (b)(4) of (b)(4)…

Cleaning procedures are not est ablis hed, Specifically,

The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures.

The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.

The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures.