Overview
- 7 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-05-01.
At a glance
Inspections
7
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Apr 2024 – 1 May 2024 | Foods & Cosmetics | 483 | View 483 → |
| 10 Feb 2020 – 11 Mar 2020 | Foods & Cosmetics | 483 | View 483 → |
| 7 Nov 2018 | Foods & Cosmetics | Clean | |
| 4 Feb 2016 | Foods & Cosmetics | Clean | |
| 4 Aug 2011 | Not recorded | Clean | |
| 11 Jun 2010 | Not recorded | Clean | |
| 24 Nov 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
1 May 2024
21 CFR 117.130(a)(1)
Hazard analysis - Identification of hazard
Cited by Ramanda C Gregory, Gillian B Nardelli, Janaye A Young
1 May 2024
21 CFR 117.135(c)(1)
Process preventive controls - Appropriate (Adequate)
Cited by Ramanda C Gregory, Gillian B Nardelli, Janaye A Young
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
Investigators
FDA investigators tied to this site in the record.
Michael Rosner3 insp.
Meredith L Sheridan2 insp.
William J Muszynski2 insp.
Jo-Ann C Declement2 insp.
Ramanda C Gregory1 insp.
Gillian B Nardelli1 insp.
Janaye A Young1 insp.
Teigan M Mule1 insp.
Jennifer A Bazergui1 insp.
Robert W Calais1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.130(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.135(c)(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 site report
Get the verbatim findings behind The Thomas Colace Company, LLC's 2 Form 483s
Recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat