Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-02-24.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Jan 2023 – 24 Feb 2023 | Foods & Cosmetics | 483 | View 483 → |
| 5 Jan 2021 – 12 Mar 2021 | Foods & Cosmetics | 483 | View 483 → |
| 8 Jul 2014 | Human Drugs | Clean | |
| 20 Nov 2012 | Not recorded | 483 | View 483 → |
| 26 Oct 2010 | Not recorded | Clean | |
| 23 May 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Feb 2023
21 CFR 111.103
Written procedure quality control operations material review
Cited by Brandon J Brookens, Alan D Centi
24 Feb 2023
21 CFR 111.123(a)(2)
Quality control operations - batch production records
Cited by Brandon J Brookens, Alan D Centi
24 Feb 2023
21 CFR 111.123(a)(7)
Quality control operations - finished batch, specifications
Cited by Brandon J Brookens, Alan D Centi
Investigators
FDA investigators tied to this site in the record.
Brandon J Brookens3 insp.
Maureen A Wentzel2 insp.
Alan D Centi1 insp.
Crystal A Harlan1 insp.
James M Mason1 insp.
Kyle S Hobson1 insp.
Maria A Reed1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.10(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.12 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.27(a)(7) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.403 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.415(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.105 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.12(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.123(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.123(a)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.15(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.15(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.153 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.155(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.25(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(a)(3)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(d)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.360 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.365(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(2) | 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 Hi-Tech Nutraceuticals LLC's 3 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