Chemco 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 clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements. You also failed to establish written procedures for cleaning and maintenance of equipment (21 CFR 211.67(a) and 211.67(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 drug products, such as **(b)(4)**.

Passage 4

You failed to adequately test each shipment of each lot of **(b)(4)** for **(b)(4)** contamination.

Passage 5

You failed to adequately test your incoming **(b)(4)** 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 6

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.