Overview
- 15 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-09.
At a glance
Inspections
15
Form 483s
5
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Jun 2026 – 9 Jun 2026 | Human Drugs | 483 | View 483 → |
| 17 Jul 2023 – 1 Aug 2023 | Human Drugs | 483 | View 483 → |
| 28 Aug 2017 – 30 Aug 2017 | Human Drugs | 483 | On file |
| 31 May 2016 – 7 Jun 2016 | Human Drugs | Clean | |
| 7 Jan 2014 – 21 Jan 2014 | Human Drugs | 483 | View 483 → |
| 21 Nov 2011 | Not recorded | Clean | |
| 7 Apr 2011 | Not recorded | Clean | |
| 14 Jan 2010 | Not recorded | 483 | On file |
| 18 Dec 2008 | Not recorded | Clean | |
| 5 Sep 2006 | Not recorded | Clean | |
| 19 Aug 2005 | Not recorded | Clean | |
| 7 Feb 2005 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Jun 2026
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Janet A Rajan, Stephenie M Ortiz, Suchan Kim
1 Aug 2023
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Anthony J Donato, Amatul H Marium, Victoria Spivak
1 Aug 2023
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Anthony J Donato, Amatul H Marium, Victoria Spivak
1 Aug 2023
21 CFR 211.68(b)
Computer control of master formula records
Cited by Anthony J Donato, Amatul H Marium, Victoria Spivak
1 Aug 2023
21 CFR 211.68(b)
Computer control of master formula records
Cited by Anthony J Donato, Amatul H Marium, Victoria Spivak
Investigators
FDA investigators tied to this site in the record.
Alberto A Viciedo3 insp.
Janet A Rajan1 insp.
Stephenie M Ortiz1 insp.
Suchan Kim1 insp.
Anthony J Donato1 insp.
Amatul H Marium1 insp.
Victoria Spivak1 insp.
Lata C Mathew1 insp.
Guerlain Ulysse1 insp.
Emmanuel J Ramos1 insp.
Niketa Patel1 insp.
Liatte Krueger1 insp.
Melba T Rivera Clavell1 insp.
Karen E Dorazio1 insp.
Michael Serrano1 insp.
Jonee J Mearns1 insp.
Deborah B Nixon1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind SGS North America Inc.'s 5 Form 483s
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