Roger W. Rose
President and Chief Executive Officer
Pinnacle Transplant Technologies, LLC
1125 W. Pinnacle Peak Road, Bldg. 1, Suite 103
Phoenix , AZ 85027-1390
United StatesFEI 3008927553Issued Oct 1, 2024Center for Biologics Evaluation and Research (CBER)
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3008927553.
Violations9
Issue DateOct 1, 2024
Product TypeBiologics
StatusOpen
Letter Details
Firm
Pinnacle Transplant Technologies, LLC
Location
Roger W. Rose
President and Chief Executive Officer
Pinnacle Transplant Technologies, LLC
1125 W. Pinnacle Peak Road, Bldg. 1, Suite 103
Phoenix , AZ 85027-1390
United States
FEI Number
3008927553
Country
United States
Issue Date
October 01, 2024
Issuing Office
Center for Biologics Evaluation and Research (CBER)
Product Type
Biologics
Status
Open
Summary
Pinnacle Transplant Technologies manufactured amniotic membrane and amniotic fluid-derived products (PalinGen®) marketed for wound healing and other therapeutic uses, which the FDA determined were drugs, biological products, and human cell/tissue products (HCT/Ps) subject to 21 CFR Part 1271 regulation. The inspection conducted in August 2022 identified that Pinnacle failed to comply with HCT/P regulations, though the specific regulatory deviations are redacted in the available letter excerpt. The company distributed these products nationally to third-party distributors, private label partners, and directly to healthcare facilities, representing a widespread compliance concern for products intended to be sterile.
Pinnacle Transplant Technologies, LLC FDA Warning Letter, October 1, 2024
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