Libby Laboratories, 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 for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(b)).

Passage 2

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 3

You failed to perform adequate identity testing of each component lot used in the manufacture of your OTC drug products, such as **(b)(4)** and **(b)(4)**. You also relied on your suppliers’ certificate of analysis (COA) for components, such as **(b)(4)**, and **(b)(4)**, without establishing the reliability of the suppliers’ test analyses at appropriate intervals.

Passage 4

You failed to adequately test your incoming **(b)(4)**, used as an active pharmaceutical ingredient, for **(b)(4)**. The use of **(b)(4)** contaminated with **(b)(4)** has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document **(b)(4)**.

Passage 5

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.