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FDA establishment 3011545418, Phoenix, Arizona, United States. Part of Amnio Technology's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 3
Official action indicated: 1
Last inspection ended: Aug 29, 2022
Warning letters: 1
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 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 · Vaccines and Allergenic ProductsBiologics · Human Cellular, Tissue, and Gene Therapies
4 cited references
21 CFR 600.80(c). Reporting Requirements Adverse experience information was not reported to FDA as required.
21 CFR 211.198(a). Complaint Handling Procedure Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
21 CFR 211.166(a). Lack of written stability program There is no written testing program designed to assess the stability characteristics of drug products.
21 CFR 211.100(a). Absence of Written Procedures Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
Official Action Indicated (OAI)
Mar 20, 2019
Biologics · Human Cellular, Tissue, and Gene Therapies
None posted
No Action Indicated (NAI)
Aug 23, 2016
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