Ultra Chem Labs Corporation

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 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; and your firm failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(a) and 21 CFR 211.165(b))

Passage 2

Your firm failed to conduct adequate release testing, including microbial testing, of your hand sanitizer drug product. You only conduct pH, viscosity, and clarity testing prior to release. Full release testing, including strength and identity testing of the active ingredient, must be performed before drug product release and distribution. Without adequate testing, you do not have adequate scientific evidence to assure that your drug products conform to appropriate specifications before release.

Passage 3

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 21 CFR 211.84(d)(2)).

Passage 4

Your firm failed to conduct any testing on the components used to manufacture your hand sanitizer drug product. This includes your active ingredients, benzalkonium chloride (BZK) and ULS 8357/**(b)(4)**. Additionally, your firm accepts components from your suppliers without establishing the reliability of your suppliers’ test analyses, and without obtaining your suppliers’ certificate of analysis (COA).

Passage 5

Failure to address violations may also cause the FDA to withhold issuance of Export Certificates. The 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.