Fresh Farms LLC — FDA Warning Letter Findings

Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)). You failed to perform release testing for batches of (b)(4) Hand Sanitizer labeled as containing ethanol. During the inspection, you stated that no release testing was performed on your drug products. Drug products must be tested for identity, strength, quality, and purity prior to release. Testing is essential to ensure that the drug products you manufacture conform to all pre-determined quality attributes that are appropriate for their intended use, including microbiological specifications.

Your firm failed to withhold from use each lot of components, drug product containers, and closures until the lot had been sampled, tested, or examined, as appropriate, and released for use by the quality control unit (21 CFR 211.84(a)) You failed to sample, test, and examine components used in the manufacture of your OTC drugs including ethanol which is used as an active pharmaceutical ingredient (API) in the manufacture of (b)(4) Hand Sanitizer drug product. During the…

Failure 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 211.22(d)). Your firm manufactures over the counter (OTC) Hand Sanitizer 1 drug products including (b)(4) Hand Sanitizer. Your firm’s quality systems are inadequate. Your firm failed to establish an adequate quality unit with responsibilities to ensure adequate oversight for the manufacture of…

Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188). You lacked executed batch records for batches of (b)(4) Hand Sanitizer drug product you manufactured. During the inspection, you stated that no batch records were prepared. You also stated that your employees knew the formulation and final concentration of the hand sanitizer and therefore…