Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-12-01.
At a glance
Inspections
4
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Nov 2023 – 1 Dec 2023 | Foods & Cosmetics | 483 | View 483 → |
| 24 Jan 2023 – 1 Feb 2023 | Foods & Cosmetics | WL | View 483 → |
| 30 Aug 2017 – 1 Sep 2017 | Foods & Cosmetics | 483 | View 483 → |
| 16 Apr 2013 – 17 Apr 2013 | Foods & Cosmetics | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Dec 2023
21 CFR 111.103
Written procedure quality control operations material review
Cited by Lissette Paiz
1 Dec 2023
21 CFR 111.12(b)
Personnel - quality control operations; responsibilities
Cited by Lissette Paiz
1 Feb 2023
21 CFR 111.535(b)(1)
Records - returned dietary supplement: written procedures
Cited by Lissette Paiz
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.475(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.535(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.65 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.20(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.12(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.453 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.570(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Healthtex Distributors, Inc.'s 4 Form 483s
Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat