Global Medical Production 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 adequate procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a).

Passage 2

Failure to establish and maintain procedures to control product that does not conform to specified requirements as required by 21 CFR 820.90(a).

Passage 3

Failure to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a).

Passage 4

Failure to conduct periodic inspections in accordance with established procedures to ensure adherence to applicable equipment maintenance schedules, as required by 21 CFR 820.70(g)(1).

Passage 5

Failure to identify by suitable means the acceptance status of product, to indicate the conformance or nonconformance of product with acceptance criteria, as required by 21 CFR 820.86.

Passage 6

Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).

Passage 7

Failure to maintain device master records as required by 820.181.

Passage 8

Failure to maintain device history records as required by 820.184.

Passage 9

Failure to develop, maintain and implement written a Medical Device Reporting (MDR) procedure, as required by 21 CFR 803.17. For example, during the inspection, your firm acknowledged that it does not have an MDR procedure. This is a repeat violation from the previous inspection in April 2015.