US FDA 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,

Failure to clean equipment and utensils to prevent contamination or carry-over of a material that would alter the quality of the API beyond the official or other established specifications. Your firm manufactures (b)(4) for the U.S. market. During the inspection, our investigator observed numerous scratches and (b)(4) stains on the interior API-contact surfaces of your (b)(4) vessels, as well as (b)(4) markings on the lid and rim of the (b)(4) of your (b)(4) vessel. These…

Failure to ensure that equipment is maintained. Your firm failed to adequately maintain the (b)(4) used to manufacture (b)(4) API for the U.S. market. Our investigator documented (b)(4) in the (b)(4) manufacturing workshop in various levels of disrepair, including cracked, taped, and deteriorating (b)(4) gaskets, rust-like residues on product-contact surfaces such as (b)(4) , and cracked (b)(4) inside one of the (b)(4) . These findings directly contradict your firm’s own…

Cleaning procedures are not appropriate or reproducible to prevent contamination that would alter the safety, identity, strength, quality, or purity of the finished drug substances.