IsoTis OrthoBiologics, 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 adequately establish procedures for corrective and preventive action, as required by 21 CFR 820.100(a). For example:

Passage 2

Your firm failed to adequately take action to correct the cause of nonconformities in order to prevent recurrence. Your firm's corrective and preventative action procedure, Corrective and Preventive Actions CP-1001 Rev. J Effective: 8/22/2022, requires your firm to perform an investigation, determine the need for containment, and assess the risk associated with the issue.

Passage 3

Failure to revalidate a validated process when changes or process deviations occurred, as required by 21 CFR 820.75(c). For example:

Passage 4

Failure to establish an adequate risk analysis, as required by 21 CFR 820.30(g). For example: