Warning letter
Healthtex Distributors, Inc.: warning letter of Jun 15, 2023
FDA warning letter 654453 · Division of Human and Animal Food Operations East IV
Key facts
| Reference number | 654453 |
|---|---|
| Company | Healthtex Distributors, Inc. |
| Subject | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated |
| Issue date | Jun 15, 2023 |
| Posted date | Mar 5, 2024 |
| Issuing office | Division of Human and Animal Food Operations East IV |
| Product type | Food/Cosmetics |
| CFR sections cited | 111.455(a), 101.36(b)(2), 111.453, 101, 101.36, 111, 111.103, 111.113, 101.3(g), 101.93(b), 101.4(a), 101.4(g) and 2 more |
| Inspection city | Miami |
| Inspection ZIP | 33142 |
| Inspection start date | Jan 24, 2023 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: