Sea-Long Medical Systems, LLC

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

Passage 2

Failure to establish procedures for process validation where the results of a process cannot be fully verified by subsequent inspection and test; failure to validate the process with a high degree of assurance; and failure to approve the process according to established procedures, as required by 21 CFR 820.75(a).

Passage 3

Failure to establish and maintain procedures for design change to ensure the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i).

Passage 4

Failure to establish and maintain procedures for corrective and preventive action, as required by 21 CFR 820.100(a).

Passage 5

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 6

Failure to establish and maintain procedures for finished device acceptance, to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d).

Passage 7

Failure to establish and maintain procedures for acceptance of incoming product to ensure acceptance or rejection shall be documented, as required by 21 CFR 820.80(b).

Passage 8

Failure to maintain device master records (DMRs), as required by 21 CFR 820.181.

Passage 9

Failure to establish and maintain procedures for device history records (DHRs) to ensure that 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 21 CFR part 820, as required by 21 CFR 820.184.

Passage 10

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

Passage 11

Failure to establish procedures for management review to ensure that management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency, as required by 21 CFR 820.20(c).