Overview
- 36 public-safe observations are available for this inspection.
- 30 structured CFR citations are represented.
- 8 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
Process adherence
Cited by Brian P Emanuel, Margaret Torres-Vazquez, Rafael Padilla, Maria Diaz, Leslie D Hintz, Lauren A Crivellone, William D Sherman, Jessica L Burley
Record retention
Cited by Brian P Emanuel, Margaret Torres-Vazquez, Rafael Padilla, Maria Diaz, Leslie D Hintz, Lauren A Crivellone, William D Sherman, Jessica L Burley
Harborage areas
Cited by Brian P Emanuel, Margaret Torres-Vazquez, Rafael Padilla, Maria Diaz, Leslie D Hintz, Lauren A Crivellone, William D Sherman, Jessica L Burley
Drainage
Cited by Brian P Emanuel, Margaret Torres-Vazquez, Rafael Padilla, Maria Diaz, Leslie D Hintz, Lauren A Crivellone, William D Sherman, Jessica L Burley
Contamination with microorganisms, chemicals, filth, etc.
Cited by Brian P Emanuel, Margaret Torres-Vazquez, Rafael Padilla, Maria Diaz, Leslie D Hintz, Lauren A Crivellone, William D Sherman, Jessica L Burley
Inspected site
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 113.89 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 110.20(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.37(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.40(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 113.40(b)(1)(v) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 108.35(c)(3)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 108.35(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(d)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(a)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.40(a)(11) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.40(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.40(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.40(i) | 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(f) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 36 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