Overview
- 6 public-safe observations are available for this inspection.
- 3 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
3 Jun 2016
21 CFR 111.103
Written procedures - quality control operations
Cited by Zada L Giles, Patrick C Dooley
3 Jun 2016
21 CFR 111.103
Written procedures - quality control operations
Cited by Zada L Giles, Patrick C Dooley
3 Jun 2016
21 CFR 111.123(b)(2)
Quality control - batch, product specifications
Cited by Zada L Giles, Patrick C Dooley
3 Jun 2016
21 CFR 111.123(b)(2)
Quality control - batch, product specifications
Cited by Zada L Giles, Patrick C Dooley
3 Jun 2016
21 CFR 111.123(b)(3)
Quality control - batch released, adulteration
Cited by Zada L Giles, Patrick C Dooley
Inspected site
PLPharmavite LLC - OpelikaOpelika, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.123(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.123(b)(3) | Cited across public-safe Form 483 observations | 2x |
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