Diamond Chemical Co., Inc.

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 test samples of each component for identity and conformity with all appropriate written specifications for purity 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 2

You failed to conduct an identity test on each shipment of each lot of components used in the manufacture of your over-the-counter (OTC) drug products, including your active ingredient ethanol. Additionally, you relied on the certificates of analysis (COAs) from your suppliers but failed to establish the reliability of each of your component suppliers’ test analyses at appropriate intervals.

Passage 3

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)).

Passage 4

Your firm failed to adequately test your drug products for the identity and strength of the active ingredient ethanol prior to release and distribution.

Passage 5

Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).

Passage 6

Your firm failed to adequately validate the processes used to manufacture at least **(b)(4)** batches of your hand sanitizer drug products.

Passage 7

Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products (21 CFR 211.166(a)).

Passage 8

Your firm did not establish an adequate ongoing stability testing program to demonstrate that your hand sanitizer drug products met established specifications for identity, strength, quality, and purity for the duration of their shelf lives.

Passage 9

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.