Overview
- 6 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
21 Feb 2012
21 CFR 111.73
Specifications met - contamination limits
Cited by Phal K Chhun, Marcus F Yambot, Trushani T Desai
21 Feb 2012
21 CFR 111.73
Specifications met - identity, purity, strength, composition
Cited by Phal K Chhun, Marcus F Yambot, Trushani T Desai
21 Feb 2012
21 CFR 111.75(a)(1)(i)
Component - verify identity, dietary ingredient
Cited by Phal K Chhun, Marcus F Yambot, Trushani T Desai
21 Feb 2012
21 CFR 111.123(a)(8)
Quality control - finished batch, distribution
Cited by Phal K Chhun, Marcus F Yambot, Trushani T Desai
21 Feb 2012
21 CFR 111.255(b)
Batch record - complete
Cited by Phal K Chhun, Marcus F Yambot, Trushani T Desai
Inspected site
PLPinnacle Labs International, Inc.Upland, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.73 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.123(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.320(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 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