Overview
- 8 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 6 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
Oversight of production operations
Cited by Marijo B Kambere, Barbara J Breithaupt, James S Stuart, Diane T Wade, Marquessa M Rowe, Deborah L Wade
Equipment not suitable
Cited by Marijo B Kambere, Barbara J Breithaupt, James S Stuart, Diane T Wade, Marquessa M Rowe, Deborah L Wade
Analytical methods
Cited by Marijo B Kambere, Barbara J Breithaupt, James S Stuart, Diane T Wade, Marquessa M Rowe, Deborah L Wade
Data and documentation review
Cited by Marijo B Kambere, Barbara J Breithaupt, James S Stuart, Diane T Wade, Marquessa M Rowe, Deborah L Wade
Oversight of production operations
Cited by Marijo B Kambere, Barbara J Breithaupt, James S Stuart, Diane T Wade, Marquessa M Rowe, Deborah L Wade
Inspected site
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 212.20(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 212.30(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 212.60(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 212.70(d)(2) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 8 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