Beijing Xinggu Lvsan Technology Co., Ltd. Formerly known as Beijing Lvsan Technology 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

Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).

Passage 3

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 4

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 5

You failed to validate the manufacturing processes for your OTC hand sanitizer drug products. For example, you have not sufficiently identified critical manufacturing variables including, but not limited to, **(b)(4)** and time. You did not demonstrate that your manufacturing processes were controlled to consistently yield a drug product of uniform character and quality.