Overview
- 22 public-safe observations are available for this inspection.
- 11 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
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
15 Feb 2019
21 CFR 211.160(b)(3)
Acceptance of drug products
Cited by Saleem A Akhtar, Rebecca E Dombrowski
15 Feb 2019
21 CFR 211.192
Written record of investigation incomplete
Cited by Saleem A Akhtar, Rebecca E Dombrowski
15 Feb 2019
21 CFR 211.194(a)(3)
Statement of Sample Weights and Measures
Cited by Saleem A Akhtar, Rebecca E Dombrowski
Inspected site
DHDEVA HOLDING ANONIM SIRKETI - CERKEZKOY SUBESIKapakli, Turkey
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| 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)(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 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 22 observations
Every observation in full, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere