Overview
- 15 public-safe observations are available for this inspection.
- 12 structured CFR citations are represented.
- 5 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
Notify FDA - spoilage
Cited by Elizabeth S Howell, David J Gomes, Kristina M Phelps, Jason T Lovelady, Margo.C.L. Jones
Recall procedures
Cited by Elizabeth S Howell, David J Gomes, Kristina M Phelps, Jason T Lovelady, Margo.C.L. Jones
Adjusted to agree with TID
Cited by Elizabeth S Howell, David J Gomes, Kristina M Phelps, Jason T Lovelady, Margo.C.L. Jones
Unauthorized adjustment
Cited by Elizabeth S Howell, David J Gomes, Kristina M Phelps, Jason T Lovelady, Margo.C.L. Jones
Observable
Cited by Elizabeth S Howell, David J Gomes, Kristina M Phelps, Jason T Lovelady, Margo.C.L. Jones
Inspected site
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 113.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 113.40(a)(2)(iii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 113.60(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 108.35(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 108.35(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.40(a)(13)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.40(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.60(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.60(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.87(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.89 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.11(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 15 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