Salon Technologies International, 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 conduct impurity testing, including acetal, acetaldehyde, and benzene, of active pharmaceutical ingredients or for your finished hand sanitizer drug products prior to distribution. Because these impurities are a known risk of the manufacturing process, a finished product specification for these impurities in hand sanitizers is appropriate under 21 CFR 211.160(b). Further, finished product testing of each batch of drug product is required under 21 CFR 211.165.

Passage 2

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 inspect to verify that you have completed corrective actions to address any violations.