Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-12-06.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Dec 2023 – 6 Dec 2023 | Human Drugs | Clean | |
| 17 Jul 2023 – 25 Jul 2023 | Human Drugs | 483 | View 483 → |
| 23 Jul 2015 – 30 Jul 2015 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Jul 2023
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Michael A Charles
25 Jul 2023
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Michael A Charles
Investigators
FDA investigators tied to this site in the record.
Makini Cobourne-Duval1 insp.
Hasan A Irier1 insp.
Mei Ou1 insp.
Michael A Charles1 insp.
Patric C Klotzbuecher1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind DEVA HOLDING A S-KARTEPE URETIM TESISLERI's 2 Form 483s
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