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FDA establishment 3011152407, Las Vegas, Nevada, United States. Part of AnazaoHealth Corporation's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 5
Official action indicated: 5
Last inspection ended: Aug 8, 2025
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 4 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.
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, written and followed.
21 CFR 211.194(a). Complete test data included in records Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
21 CFR 211.198(b)(2). Complaint Investigation/Follow-Up Findings Complaint records are deficient in that they do not include the findings of the investigation and follow-up.
21 CFR 211.100(a). Absence of Written Procedures Your firm failed to establish adequate 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)
Sep 23, 2024
Drugs · Drug Quality Assurance
None posted
Official Action Indicated (OAI)
Jul 29, 2022
Drugs · Drug Quality Assurance
None posted
Official Action Indicated (OAI)
Sep 19, 2019
Drugs · Drug Quality Assurance
2 cited references
21 CFR 211.42(b). Product flow through building is inadequate The flow of components, drug product containers, closures and in-process materials though the building is not designed to prevent contamination.
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.
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. 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 and warning letters
Las Vegas, Nevada, United States. Part of