Yangzhou Yulou Paper Products 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 and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes. Your firm also failed to establish laboratory controls that include scientifically sound and appropriate specifications designed to ensure conformance with appropriate standards of identity, strength, quality, and purity. (21 CFR 211.113(b) and 211.160(b))

Passage 2

Your firm failed to conduct at least one test to verify the identity of each component of a drug product. (21 CFR 211.84(d)(1))

Passage 3

Your firm failed to establish and follow a written testing program designed to assess the stability characteristics of drug products. (21 CFR 211.166(a))

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

Your firm failed to establish written responsibilities and procedures applicable to the quality control unit and to follow such written procedures. (21 CFR 211.22(d))