Max Chemical 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 test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. (21 CFR 211.84(d)(1) and 211.84(d)(2)).

Passage 2

You failed to conduct an identity test on each shipment of each lot of components used in the production of your drug products, including the active ingredients (i.e., isopropyl and ethyl alcohol). Additionally, you relied on the certificates of analysis (COAs) from your suppliers and failed to establish the reliability of each of your suppliers’ COAs for component specifications and characteristics.

Passage 3

Your firm failed to establish 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. (21 CFR 211.100(a)).

Passage 4

Your firm failed to establish an adequate quality unit (QU) with responsibilities to ensure adequate oversight for the manufacture of your drug products. For example, your QU failed to ensure:

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.