Overview
- 10 public-safe observations are available for this inspection.
- 10 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.
18 Sep 2015
21 CFR 111.103
Written procedures - quality control operations
Cited by Mancia R Walker, Perry H Gambrell
18 Sep 2015
21 CFR 111.353
Manufacturing operations - written procedures
Cited by Mancia R Walker, Perry H Gambrell
18 Sep 2015
21 CFR 111.535(b)(2)
Records - ret'nd dietary supplement: material review, dispos
Cited by Mancia R Walker, Perry H Gambrell
18 Sep 2015
21 CFR 111.553
Written procedures - product complaint
Cited by Mancia R Walker, Perry H Gambrell
18 Sep 2015
21 CFR 111.60(a)
Production, in- process control system - design, quality
Cited by Mancia R Walker, Perry H Gambrell
Inspected site
APAmerican Pure WheyNew Bern, United States
Inspection team
PHPerry H Gambrell
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 | 1x |
| 21 CFR 111.20(h) | 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 111.353 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.535(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.60(a) | 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(c) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 10 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