Kath Khemicals 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 have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. Your firm also 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(a) and 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 (21 CFR 211.84(d)(1).

Passage 3

Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products (21 CFR 211.166(a)).

Passage 4

You failed to establish an adequate stability testing program to demonstrate that the chemical and microbiological properties of your drug products meets established specifications and remain acceptable through the 12-month expiration period for your drug products. During the inspection, you informed our investigator that reserve samples stored are also considered stability samples. You indicated that you only inspect them visually for color appearance and do not record the results.

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.