Overview
- 9 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-05-27.
At a glance
Inspections
9
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 May 2022 – 27 May 2022 | Human Drugs | 483 | View 483 → |
| 16 Oct 2018 – 17 Oct 2018 | Human Drugs | Clean | |
| 14 Dec 2015 – 16 Dec 2015 | Human Drugs | 483 | View 483 → |
| 27 Mar 2014 – 31 Mar 2014 | Human Drugs | 483 | View 483 → |
| 18 Mar 2011 | Not recorded | 483 | On file |
| 3 Sep 2009 | Not recorded | 483 | On file |
| 16 Jul 2007 | Not recorded | Clean | |
| 24 May 2005 | Not recorded | Clean | |
| 6 Feb 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
27 May 2022
21 CFR 211.125(a)
Strict control not exercised over labeling issued
Cited by Demario L Walls
16 Dec 2015
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Tamara J Henderson, Lauryl A Smith
16 Dec 2015
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Tamara J Henderson, Lauryl A Smith
16 Dec 2015
21 CFR 211.103
Actual vs. theoretical yields not determined
Cited by Tamara J Henderson, Lauryl A Smith
16 Dec 2015
21 CFR 211.194(d)
Laboratory equipment calibration records
Cited by Tamara J Henderson, Lauryl A Smith
Investigators
FDA investigators tied to this site in the record.
Tamara J Henderson3 insp.
Jawaid Hamid2 insp.
Demario L Walls1 insp.
Lauryl A Smith1 insp.
Xiomara Copeland1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind S.s.s. Company (international)'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