Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-01-17.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Dec 2023 – 17 Jan 2024 | Foods & Cosmetics | 483 | View 483 → |
| 4 Dec 2017 – 5 Dec 2017 | Foods & Cosmetics | Clean | |
| 29 Jul 2015 – 31 Jul 2015 | Foods & Cosmetics | Clean | |
| 9 Sep 2013 – 12 Sep 2013 | Foods & Cosmetics | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Jan 2024
21 CFR 111.70(b)(2)
Specifications-component purity, strength, composition
Cited by Jorge L Bertran
17 Jan 2024
21 CFR 111.70(e)
Specifications - identity, purity, strength, composition
Cited by Jorge L Bertran
Investigators
FDA investigators tied to this site in the record.
Jorge L Bertran1 insp.
Lourdes Andujar1 insp.
Lesley A Swanson1 insp.
James S Cartwright1 insp.
Michael S Valenzuela1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.260(k)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.10(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.10(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.113(a)(2) | 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(f)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(h)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(h)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(h)(3)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(h)(3)(ii)(B) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(h)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(j)(2)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(j)(2)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(j)(2)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(j)(2)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(k)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(a)(5)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.30(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.35(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.410(c) | 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(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Aqueous Labs, Inc.'s 2 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