Anhui Hanbon Daily Chemical 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 test samples of each component for specific 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

Your firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)).

Passage 3

You failed to establish the adequacy of release testing procedures, and you released batches of drug products for distribution without conducting adequate testing to confirm critical quality attributes. For example, you did not use USP chemical and microbiological methods to test incoming drug substance or to test and release finished drug product, nor did you show equivalency or superiority for your alternate in-house methods.

Passage 4

Your firm failed to establish and follow a written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).

Passage 5

Your firm failed to establish an adequate stability program, which includes data from long-term or accelerated storage conditions to demonstrate that your product remains acceptable throughout its labeled expiry period. Without appropriate stability studies, there is no scientific evidence to support that your drug product retains its quality attributes throughout the labeled **(b)(4)** expiry period.

Passage 6

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 7

Your firm failed to adequately validate the manufacturing process for your drug product. You do not have assurance that you are capable of consistently manufacturing your drug product with defined quality attributes. Your firm lacks process qualification and data to support fundamental process parameters.