Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1you failed to validate the manufacturing process for your dehydrated, dual layer amniotic membrane patch, TheraMend, which cannot be fully verified, to ensure that your process does not cause contamination or cross-contamination and prevents the introduction, transmission or spread of communicable disease through the use of the HCT/P. Since August 2023, your firm has processed TheraMend products and distributed those products without a validated process.
Passage 2a listing and interpretation of the results of all communicable disease tests is not included on the *Notification of Requirements to Maintain Traceability of Human Tissue-Based Products or Instructions for Use and Product Information* forms, which are considered accompanying records as described in 21 CFR 1271.55(a).
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 1271
- 21 CFR 1271.230(a)
- 21 CFR 1271.55(b)(2)
- 21 CFR 1271.55(a)
- 21 CFR 1271.55(a)(2)