Overview
- 8 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-06-27.
At a glance
Inspections
8
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Jun 2024 – 27 Jun 2024 | Foods & Cosmetics | 483 | On file |
| 29 Oct 2019 – 31 Oct 2019 | Foods & Cosmetics | 483 | View 483 → |
| 24 Oct 2016 – 26 Oct 2016 | Foods & Cosmetics | 483 | View 483 → |
| 23 Aug 2016 | Foods & Cosmetics | Clean | |
| 4 Mar 2013 – 12 Mar 2013 | Foods & Cosmetics | 483 | View 483 → |
| 1 Dec 2004 | Not recorded | Clean | |
| 30 Dec 2003 | Not recorded | Clean | |
| 12 Sep 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
31 Oct 2019
21 CFR 111.120(e)
Quality control operations - quarantine
Cited by Sparky L Bartee, Paul F Rader
31 Oct 2019
21 CFR 111.120(e)
Quality control operations - quarantine
Cited by Sparky L Bartee, Paul F Rader
31 Oct 2019
21 CFR 111.123(a)(7)
Quality control operations - finished batch, specifications
Cited by Sparky L Bartee, Paul F Rader
31 Oct 2019
21 CFR 111.123(a)(7)
Quality control operations - finished batch, specifications
Cited by Sparky L Bartee, Paul F Rader
31 Oct 2019
21 CFR 111.120(e)
Quality control operations - quarantine
Cited by Sparky L Bartee, Paul F Rader
Investigators
FDA investigators tied to this site in the record.
Gary C Pecic1 insp.
Natalie J Reese1 insp.
Anna L Marroquin1 insp.
Sparky L Bartee1 insp.
Paul F Rader1 insp.
Natalie J Ayoub1 insp.
CntrctMntr LewisJess1 insp.
Sara J Dent Acosta1 insp.
Matthew J Johnson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.120(e) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 111.123(a)(7) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.260(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.10(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.10(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.15(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.155(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.165(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(h)(3)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.23(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.320(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c)(3) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind CSI's 4 Form 483s
Verbatim observations and 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