Cosmetic Science Laboratories 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 conduct at least one test to verify the identity of each component of a drug product. 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 test your incoming active pharmaceutical ingredients (APIs) for identity prior to manufacturing your bulk over-the-counter (OTC) drug products, including SPF-50 **(b)(4)** Sunscreen. Additionally, you relied on certificates of analysis (COAs) from your suppliers to use incoming APIs without establishing the reliability of the specifications and characteristics of each supplier’s COAs.

Passage 3

Your firm failed to establish adequate 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. Your firm also 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 211.100 (a) and 21 CFR211.188).

Passage 4

Your firm did not provide process validation documents for your contract manufactured over-the-counter (OTC) bulk drug products. During the inspection, you failed to provide your protocols, reports, or data to support that each OTC drug product met predetermined quality requirements consistently and reliably.

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.