Ningbo Riway Industrial Co., 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 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

You failed to adequately test your incoming IPA, which is used as an active ingredient, for methanol. The use of IPA contaminated with methanol has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document *Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol* to help you meet the CGMP requirements when manufacturing drugs containing IPA at https://www.fda.gov/media/173005/download.

Passage 3

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 (21 CFR 211.165(a)).

Passage 4

Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).