Lico Industries, LLC., d.b.a. American Towelette Company

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your firm failed to establish an adequate quality unit, and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and (d)).

Passage 2

Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).

Passage 3

Your firm failed to adequately clean and maintain non-dedicated drug manufacturing equipment used to fill OTC drug products. For example, our investigator observed stagnant **(b)(4)** product residue inside the tubing on the filling line with residue accumulating in crevices and on surfaces that come into direct contact with the drug product.