Overview
- 21 public-safe observations are available for this inspection.
- 19 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.
27 Feb 2015
21 CFR 111.140(b)(3)(vii)
material review, disposition, follow-up; signature
Cited by Brett R Havranek, Janete A Oliveira, Janete A Eaker
27 Feb 2015
21 CFR 111.255(b)
Batch record - complete
Cited by Brett R Havranek, Janete A Oliveira, Janete A Eaker
27 Feb 2015
21 CFR 111.70(f)
Specifications - product received for packaging, labeling
Cited by Brett R Havranek, Janete A Oliveira, Janete A Eaker
27 Feb 2015
21 CFR 211.160(a)
Lab controls established, including changes
Cited by Brett R Havranek, Janete A Oliveira, Janete A Eaker
27 Feb 2015
21 CFR 211.165(a)
Testing and release for distribution
Cited by Brett R Havranek, Janete A Oliveira, Janete A Eaker
Inspected site
GHGrato Holdings, Inc.Woodbine, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.140(b)(3)(vii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.52 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.89 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 21 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