DermaRite Industries, LLC

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 thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192)

Passage 2

Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).

Passage 3

You failed to perform adequate identity testing on each shipment of each lot of incoming components (e.g., ethanol, glycerin) used in the manufacture of your OTC drug products. In addition, you relied on your suppliers’ certificate of analysis (COA) without establishing the reliability of each of your component suppliers’ test analyses at appropriate intervals.

Passage 4

Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products, and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).

Passage 5

Your firm did not have an adequate stability program to demonstrate that the chemical and microbiological properties of your drug products met established specifications and that they remain acceptable throughout their labeled shelf-life. For example, you failed to place any OTC drug products on stability in 2023 or 2024.

Passage 6

Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.