Overview
- 8 public-safe observations are available for this inspection.
- 8 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
11 Jun 2013
21 CFR 111.35(b)(1)(ii)
Procedures - equipment; calibrating, inspecting, checking
Cited by Thao T Kwan
11 Jun 2013
21 CFR 111.35(b)(2)
Document-equipment date of use, maintain, clean, sanitize
Cited by Thao T Kwan
11 Jun 2013
21 CFR 111.70(b)(2)
Specifications-component purity, strength, composition
Cited by Thao T Kwan
11 Jun 2013
21 CFR 111.70(e)
Specifications - identity, purity, strength, composition
Cited by Thao T Kwan
Inspected site
SUSterling USA Nutraceuticals Lab, LLCGlendale, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.105(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.35(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.35(b)(2) | 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(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 observations
Every observation in full, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere