Cohere Beauty

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 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 (21 CFR 211.100(a)).

Passage 2

Your firm failed to validate the manufacturing processes for your over-the-counter (OTC) drug product **(b)(4)**. During the inspection, you could not provide process validation studies for the **(b)(4)** drug product. You manufactured, released, and distributed at least **(b)(4)** lots of **(b)(4)** in 2023, and you failed to demonstrate that your manufacturing process were controlled to consistently yield a drug product of uniform character and quality.

Passage 3

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.