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FDA establishment 3008927553, Phoenix, Arizona, United States. Part of Pinnacle Transplant Technologies's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
Inspections: 5
Official action indicated: 1
Last inspection ended: Aug 29, 2022
Warning letters: 1
Recalls since 2016: 2
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
Biologics · Human Cellular, Tissue, and Gene TherapiesBiologics · Vaccines and Allergenic Products
5 cited references
21 CFR 211.42(c)(10)(v). Cleaning System Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
21 CFR 211.113(b). Validation lacking for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
21 CFR 211.42(c)(10)(iv). Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Official Action Indicated (OAI)
Feb 28, 2020
Biologics · Human Cellular, Tissue, and Gene TherapiesBiologics · Vaccines and Allergenic Products; Biologics · Blood and Blood Products
3 cited references
21 CFR 211.113(b). Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.
21 CFR 211.113(b). Validation lacking for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include validation of the aseptic and sterilization process.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Voluntary Action Indicated (VAI)
Aug 9, 2017
Biologics · Human Cellular, Tissue, and Gene Therapies
None posted
No Action Indicated (NAI)
Jul 16, 2014
Biologics · Human Cellular, Tissue, and Gene Therapies
None posted
No Action Indicated (NAI)
Feb 25, 2012
Biologics · Human Cellular, Tissue, and Gene Therapies
None posted
No Action Indicated (NAI)
Warning Letters
Letters naming this establishment; each opens the letter
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard, warning letters and enforcement reports
Phoenix, Arizona, United States. Part of