Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-07-13.
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 |
|---|---|---|---|
| 28 Jun 2022 – 13 Jul 2022 | Foods & Cosmetics | 483 | View 483 → |
| 11 Aug 2016 – 12 Aug 2016 | Foods & Cosmetics | 483 | View 483 → |
| 4 Jun 2013 – 11 Jun 2013 | Foods & Cosmetics | 483 | View 483 → |
| 21 May 2012 | Not recorded | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Jul 2022
21 CFR 111.205(b)(1)
Master manufacturing record-specifications; packaged, label
Cited by Sundy V Sedwick
13 Jul 2022
21 CFR 111.70(e)
Specifications - identity, purity, strength, composition
Cited by Sundy V Sedwick
Investigators
FDA investigators tied to this site in the record.
Sundy V Sedwick1 insp.
Taichun Qin1 insp.
Greg K Keshishyan1 insp.
Thao T Kwan1 insp.
Comyar Shoghi1 insp.
Sundy Ven1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.255(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.35(b)(1)(ii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.35(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.105(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.14(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.325(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.35(b)(1)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.35(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.65 | 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 111.75(a)(1)(i) | 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(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sterling USA Nutraceuticals Lab, LLC'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