Tianjin Darentang Jingwanhong Pharmaceutical 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 clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).

Passage 2

You failed to demonstrate that your cleaning practices are adequate to remove contaminants from equipment used to manufacture your topical drug product, "**(b)(4)**." On March 19, 2024, our investigators observed residues on filling machines ID-192 and ID-197, despite both being identified as clean.

Passage 3

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)).