Meridian Bioscience, Inc

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 implementing corrective and preventive action. The procedures shall include requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems, as required by 21 CFR 820.100(a).

Passage 2

Failure to validate a process with a high degree of assurance and approved according to established procedures, when the results of a process cannot be fully verified by subsequent inspection and test. The validation activities and results, including the date and signature of the individual(s) approving the validation and where appropriate the major equipment validated, shall be documented, as required by 21 CFR 820.75(a). For example:

Passage 3

Failure to establish and maintain procedures for acceptance of incoming product. Incoming product shall be inspected, tested, or otherwise verified as conforming to specified requirements. Acceptance or rejection shall be documented, as required by 21 CFR 820.80(b).

Passage 4

Failure to have written sampling plans that are based on a valid statistical rationale. Each manufacturer shall establish and maintain procedures to ensure that sampling methods are adequate for their intended use and to ensure that when changes occur the sampling plans are reviewed. These activities shall be documented, as required by 21 CFR 820.250(b).

Passage 5

Failure to report to us the information required by § 803.52 in accordance with the