Guangxi Yulin Pharmaceutical Group 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 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 2

Your firm failed to adequately determine the appropriate laboratory testing necessary for your **(b)(4)** over the counter (OTC) drug products. For example, you did not perform testing for identity and strength of the active ingredients prior to drug product release and distribution. This is a repeat observation from the 2016 inspection.

Passage 3

Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).

Passage 4

Your firm failed to demonstrate that your test methods were appropriate to assure that your product conforms to appropriate standards of identity, strength, quality, and purity. For example, your test methods and specifications are based on the Chinese Pharmacopeia (ChP). However, you failed to establish that these test methods and specifications are scientifically sound and appropriate, or that they are equivalent to or better than the current United States Pharmacopeia (USP) compendial methods.

Passage 5

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 6

Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)).