Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
11 Mar 2020
21 CFR 117.130(a)(1)
Hazard Analysis - Identification of Hazard
Cited by Teigan M Mule, Michael Rosner, Jennifer A Bazergui
11 Mar 2020
21 CFR 117.150(d)
Sanitation Controls Corrective Action Records
Cited by Teigan M Mule, Michael Rosner, Jennifer A Bazergui
11 Mar 2020
21 CFR 117.155(b)
Sanitation Controls - Verification Records
Cited by Teigan M Mule, Michael Rosner, Jennifer A Bazergui
11 Mar 2020
21 CFR 117.165(b)
Other Controls Verification Procedures: Establish Implement
Cited by Teigan M Mule, Michael Rosner, Jennifer A Bazergui
Inspected site
TTThe Thomas Colace Company, LLCWest Deptford, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.130(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.150(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.155(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.165(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 observations
The full inspection record, as Atlas holds it, 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