Overview
- 2 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2020-03-11.
At a glance
Inspections
2
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Mar 2020 – 11 Mar 2020 | Foods & Cosmetics | Clean | |
| 10 Aug 2016 – 16 Aug 2016 | Foods & Cosmetics | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Aug 2016
21 CFR 118.10(b)(3)
Signature and date on SE plans
Cited by Osama M Hamoud, Nina D Patel, Collins M Mason
16 Aug 2016
21 CFR 118.4
No written SE prevention plan
Cited by Osama M Hamoud, Nina D Patel, Collins M Mason
16 Aug 2016
21 CFR 118.4
Written SE plan lacks required elements
Cited by Osama M Hamoud, Nina D Patel, Collins M Mason
16 Aug 2016
21 CFR 118.4
Written SE plan not implemented/followed
Cited by Osama M Hamoud, Nina D Patel, Collins M Mason
Investigators
FDA investigators tied to this site in the record.
Osama M Hamoud2 insp.
Mohamad A Chahine1 insp.
Angela L Hatzenbuhler1 insp.
Nina D Patel1 insp.
Collins M Mason1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 118.4 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 118.10(b)(3) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Jared Petre #21's 1 Form 483
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