Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-07-10.
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 |
|---|---|---|---|
| 8 Jul 2024 – 10 Jul 2024 | Foods & Cosmetics | 483 | View 483 → |
| 12 May 2021 – 2 Jun 2021 | Foods & Cosmetics | 483 | View 483 → |
| 9 Jul 2019 – 15 Jul 2019 | Foods & Cosmetics | 483 | View 483 → |
| 23 Sep 2016 – 30 Sep 2016 | Foods & Cosmetics | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Jul 2024
21 CFR 111.205(b)(1)
Master manufacturing record - specifications; quality
Cited by Quynh Strandberg, Natalie J Reese
10 Jul 2024
21 CFR 111.70(b)(1)
Specifications - component identity
Cited by Quynh Strandberg, Natalie J Reese
10 Jul 2024
21 CFR 111.70(b)(2)
Specifications-component purity, strength, composition
Cited by Quynh Strandberg, Natalie J Reese
10 Jul 2024
21 CFR 111.70(e)
Specifications - identity, purity, strength, composition
Cited by Quynh Strandberg, Natalie J Reese
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 111.70(b)(2) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 110.37(e)(6) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.160(d)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.20(h) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.210(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.260(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.260(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.260(j)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.30(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.35(b)(1)(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.35(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.73 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.123(a)(2) | 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(h)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(g) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site'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