Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-08-04.
At a glance
Inspections
5
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Jul 2023 – 4 Aug 2023 | Human Drugs | 483 | View 483 → |
| 19 Sep 2022 – 23 Sep 2022 | Human Drugs | Clean | |
| 4 Feb 2019 – 15 Feb 2019 | Human Drugs | WL | View 483 → |
| 14 Jan 2019 – 18 Jan 2019 | Human Drugs | 483 | On file |
| 3 Aug 2015 – 6 Aug 2015 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Aug 2023
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Michael A Charles
15 Feb 2019
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Saleem A Akhtar, Rebecca E Dombrowski
15 Feb 2019
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Saleem A Akhtar, Rebecca E Dombrowski
Investigators
FDA investigators tied to this site in the record.
Michael A Charles1 insp.
Anastasia M Shields1 insp.
Saleem A Akhtar1 insp.
Rebecca E Dombrowski1 insp.
Xiaohan Cai1 insp.
Patric C Klotzbuecher1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 3x |
| 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)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind DEVA HOLDING ANONIM SIRKETI - CERKEZKOY SUBESI'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