Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-10-04.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Sep 2023 – 4 Oct 2023 | Foods & Cosmetics | 483 | View 483 → |
| 14 Jun 2021 – 17 Jun 2021 | Foods & Cosmetics | 483 | View 483 → |
| 31 Jul 2018 – 3 Aug 2018 | Foods & Cosmetics | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Oct 2023
21 CFR 111.123(a)(7)
Quality control operations - finished batch, specifications
Cited by Jorge L Bertran
4 Oct 2023
21 CFR 111.123(a)(7)
Quality control operations - finished batch, specifications
Cited by Jorge L Bertran
4 Oct 2023
21 CFR 117.135(c)(3)
Sanitation preventive controls - Appropriate (Adequate)
Cited by Jorge L Bertran
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 111.120(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.123(a)(7) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.123(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.130(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.135 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.83(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.135(c)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(a)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site'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