Bioptimal International

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 adequately maintain complaint files and establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a) and (d). For example:

Passage 2

Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA), specifically, verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a). For example:

Passage 3

Failure to establish and maintain procedures to validate device design to ensure that devices conform to defined user needs and intended uses, and include risk analysis where appropriate, as required by 21 CFR 820.30(g). For example:

Passage 4

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. For example:

Passage 5

Failure to establish and maintain device history record (DHR) procedures to ensure that DHRs for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record, as required by 21 CFR 820.184(e) and (f). For example:

Passage 6

Failure to adequately develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. For example, during the inspection, your firm identified the document titled "Vigilance reporting and recalls/FSCA for USFDA", BPI-WI-010, Rev. 01, dated 10/26/2023 as its written MDR procedure. After reviewing the procedure, the following deficiencies were noted:

Passage 7

Failure to submit a report to FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1). For example: