Overview
- 7 public-safe observations are available for this inspection.
- 7 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.
26 Apr 2012
21 CFR 111.35(b)(3)
Documentation - instruments, controls; calibrations
Cited by Natasha A Dezinna, Rachel C Harrington
26 Apr 2012
21 CFR 111.80(c)
Specifications - representative samples; finished batch
Cited by Natasha A Dezinna, Rachel C Harrington
26 Apr 2012
21 CFR 111.210(h)(1)
Instructions; specifications; quality
Cited by Natasha A Dezinna, Rachel C Harrington
26 Apr 2012
21 CFR 111.210(h)(2)
Master manufacturing record - sampling, tests, examinations
Cited by Natasha A Dezinna, Rachel C Harrington
Inspected site
CNCalwood Nutritionals, LLC.Sykesville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.155(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(h)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(h)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.303 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.320(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.35(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.80(c) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 7 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