Kari Gran 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 (b)(4) 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 (2)).

Passage 2

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. Your firm also failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.100 (a) and 21 CFR 211.188).

Passage 3

You failed to adequately validate your manufacturing processes for your OTC drug products, which would provide assurance that you are capable of consistently delivering a quality product. Specifically, your protocol lacked details on critical manufacturing variables including, but not limited to, mixing time and temperature. You did not demonstrate that your manufacturing processes were controlled to consistently yield a drug product of uniform character and quality.

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.