Overview
- 8 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2024-11-20.
At a glance
Inspections
8
Form 483s
1
EIRs
2
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Nov 2024 – 20 Nov 2024 | Human Drugs | Clean | |
| 15 Nov 2021 – 22 Nov 2021 | Human Drugs | Clean | |
| 16 Jul 2018 – 17 Jul 2018 | Human Drugs | Clean | |
| 2 May 2018 – 3 May 2018 | Human Drugs | Clean | |
| 6 Oct 2016 – 11 Oct 2016 | Human Drugs | Clean | |
| 21 Jun 2016 – 29 Jun 2016 | Human Drugs | 483 | View 483 → |
| 5 Nov 2013 | Human Drugs | Clean | |
| 2 Sep 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Jun 2016
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Guerlain Ulysse, Marcellinus D Dordunoo, Yvins Dezan
29 Jun 2016
21 CFR 211.142(b)
Storage under appropriate conditions
Cited by Guerlain Ulysse, Marcellinus D Dordunoo, Yvins Dezan
29 Jun 2016
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Guerlain Ulysse, Marcellinus D Dordunoo, Yvins Dezan
29 Jun 2016
21 CFR 211.192
Written record of investigation incomplete
Cited by Guerlain Ulysse, Marcellinus D Dordunoo, Yvins Dezan
29 Jun 2016
21 CFR 211.198(a)
Procedures to be written and followed
Cited by Guerlain Ulysse, Marcellinus D Dordunoo, Yvins Dezan
Investigators
FDA investigators tied to this site in the record.
Helen Verdel3 insp.
Guerlain Ulysse2 insp.
Marcellinus D Dordunoo2 insp.
Yvins Dezan2 insp.
Syeda N Mahazabin1 insp.
Alisha B Patel1 insp.
John D Mcintosh1 insp.
Rose L Jean-Mary1 insp.
Ankur C Patel1 insp.
Melissa T Roy1 insp.
Monika Borkowska1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Nutra-Med Packaging LLC's 1 Form 483
Source PDFs, 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