Patcos Cosmetics Pvt. Ltd.

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 maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair (21 CFR 211.58).

Passage 2

Your firm failed to maintain your facility in a good state of repair. During a 2017 FDA inspection, our investigators noted that your facility was in disrepair and had experienced flood damage to your facility and **(b)(4)** system. Our current inspectional findings were commensurate with findings from 2017, indicating that you have not properly remediated and maintained your facility. For example, in addition to the previously mentioned insanitary conditions:

Passage 3

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 4

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 (21 CFR 211.100(a)).

Passage 5

Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and (d).