Integra LifeSciences Corporation

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 acceptance activities. Acceptance activities include inspections, tests, or other verification activities; as required by 21 CFR § 820.80(a).

Passage 2

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 3

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

Passage 4

Failure to review and evaluate process changes and deviations and perform revalidation when changes or process deviations occur, as required by 21 CFR § 820.75(c).

Passage 5

Failure to establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality, as required by 21 CFR 820.70(e).

Passage 6

Failure to validate with a high degree of assurance, a process whose results cannot be fully verified by subsequent inspection and test, as required by 21 CFR § 820.75(a).