P.T. Sankei Medical Industries

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).For example:

Passage 2

Failure to adequately establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21CFR 820.50. For example:

Passage 3

Failure to adequately ensure Design History Records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part, as required by 21 CFR 820.184 For example:

Passage 4

Failure to adequately maintain device master records (DMR's), as required by 21 CFR820.181 For example:

Passage 5

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

Passage 6

Failure to establish procedures for quality audits and conduct such audits to assure that the quality system complies with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. For example:

Passage 7

Failure to adequately develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. For example, after reviewing your firm’s MDR procedure titled “Medical Device Adverse Events and Advisory Notice Report”, Document #PS-25, Revision 00, dated 3/2/2023, the following deficiencies were noted: