Qianjiang Kingphar Medical Material 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

Failure to establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality as required by 21 CFR 820.70(e).

Passage 2

Failure to establish and maintain procedures to adequately control environmental conditions, which could reasonably be expected to have an adverse effect on product quality and periodically inspect the environmental control system to verify that the system, including necessary equipment, is adequate and functioning properly, as required by 21 CFR 820.70(c).