Drug factory · FDA FEI 3011152407
AnazaoHealth Corporation
Las Vegas, Nevada, United States
Matched to FDA's records by company name, because this plant's registration on the label has expired.
Serious problems, FDA action at FDA's last inspection, Aug 8, 2025.
Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.
5 drug inspections on record since 2015: 0 with no problems, 0 with problems fixed voluntarily, 5 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 8, 2025 | Serious problems, FDA action | Drug Quality Assurance | 4 |
| Sep 23, 2024 | Serious problems, FDA action | Drug Quality Assurance | — |
| Jul 29, 2022 | Serious problems, FDA action | Drug Quality Assurance | — |
| Sep 19, 2019 | Serious problems, FDA action | Drug Quality Assurance | 2 |
| Jan 30, 2015 | Serious problems, FDA action | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Aug 8, 2025 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
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. - Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed. - Complete test data included in records 21 CFR 211.194(a)
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. - Complaint Investigation/Follow-Up Findings 21 CFR 211.198(b)(2)
Complaint records are deficient in that they do not include the findings of the investigation and follow-up.
Sep 19, 2019 inspection
- Product flow through building is inadequate 21 CFR 211.42(b)
The flow of components, drug product containers, closures and in-process materials though the building is not designed to prevent contamination. - Cleaning System 21 CFR 211.42(c)(10)(v)
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.