Aqualex 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 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 2

You failed to provide data to demonstrate that you have adequately validated your manufacturing processes used to manufacture your OTC drug product and to demonstrate that your processes are reproducible and controlled to consistently yield drugs of uniform character and quality. Specifically, you failed to provide evidence for the qualification of manufacturing equipment (e.g., tanks, **(b)(4)**, etc.).

Passage 3

Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63).

Passage 4

Your firm failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(b))

Passage 5

Your firm failed to establish and follow an adequate 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)).