NeilMed Pharmaceuticals 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 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

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 (21 CFR 211.67(a)).

Passage 3

You failed to adequately clean and maintain equipment used for manufacturing your drug products. For example, our investigator observed unidentified visible residues on direct product contact surfaces in **(b)(4)** non-dedicated mixing tanks labeled as “Cleaned” in **(b)(4)**. Furthermore, you failed to maintain cleaning and usage logs for these non-dedicated mixing tanks.

Passage 4

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.