Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-11-09.
At a glance
Inspections
6
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Nov 2023 – 9 Nov 2023 | Human Drugs | Clean | |
| 9 May 2019 – 17 May 2019 | Human Drugs | 483 | On file |
| 28 Nov 2016 – 6 Dec 2016 | Human Drugs | 483 | View 483 → |
| 13 Nov 2014 – 21 Nov 2014 | Human Drugs | 483 | View 483 → |
| 9 Nov 2012 | Not recorded | Clean | |
| 28 Oct 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Dec 2016
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Theresa Kirkham, Constance Y Fears
6 Dec 2016
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Theresa Kirkham, Constance Y Fears
6 Dec 2016
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Theresa Kirkham, Constance Y Fears
6 Dec 2016
21 CFR 211.94(b)
Protection from external factors
Cited by Theresa Kirkham, Constance Y Fears
Investigators
FDA investigators tied to this site in the record.
MRA V MillarW1 insp.
Bijoy Panicker1 insp.
Theresa Kirkham1 insp.
Constance Y Fears1 insp.
Chad N Thompson1 insp.
Azza Talaat1 insp.
Jose A Cruz Gonzalez1 insp.
Tiffani D Wilson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.101(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sintetica S.A.'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