Overview
- 7 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-06-14.
At a glance
Inspections
7
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Apr 2024 – 14 Jun 2024 | Foods & Cosmetics | 483 | View 483 → |
| 21 Jun 2022 – 5 Jul 2022 | Foods & Cosmetics | 483 | View 483 → |
| 6 Sep 2018 – 18 Sep 2018 | Foods & Cosmetics | 483 | View 483 → |
| 13 Sep 2016 – 21 Sep 2016 | Foods & Cosmetics | 483 | View 483 → |
| 11 Apr 2013 – 1 May 2013 | Foods & Cosmetics | WL | View 483 → |
| 21 Feb 2012 | Not recorded | 483 | View 483 → |
| 20 Oct 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Jun 2024
21 CFR 111.205(b)(1)
Master manufacturing record - specifications; quality
Cited by Natalie J Reese
Investigators
FDA investigators tied to this site in the record.
Marcus F Yambot3 insp.
Natalie J Reese2 insp.
Tuan D Tran1 insp.
Alexandra B Pitkin1 insp.
Phal K Chhun1 insp.
Trushani T Desai1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.73 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.123(a)(8) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.205(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.27(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.35(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(h)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.110(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.14(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.153 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.25 | 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(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.320(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.453 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.503 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(h) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Pinnacle Labs International, Inc.'s 6 Form 483s
Source PDFs, 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