GFA Production Xiamen 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, and to follow all of your written production and process control procedures (21 CFR 211.100(a) and 211.100 (b)).

Passage 2

You failed to provide data to demonstrate your drug manufacturing processes are adequately validated. After request by our investigators for process performance qualification (PPQ) you only provided equipment qualification reports during the inspection.

Passage 3

You failed to provide data to demonstrate you adequately performed cleaning validation for the equipment used to manufacture your drug products. Your cleaning validation studies, for example, did not include swab recovery limits, dirty and clean hold times, or sufficient instructions to ensure consistency.

Passage 4

You failed to provide adequate data to demonstrate manufacturing systems were adequately maintained. Your firm did not monitor and acknowledge equipment alarms according to your established procedures. For example, our investigators observed **(b)(4)** alarms silenced without documented action. Likewise, temperature and humidity alarms for your stability chambers were disabled and were observed to be out of range when enabled.

Passage 5

Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).

Passage 6

Your firm failed to establish and follow required laboratory control mechanisms (21 CFR 211.160(a)).