Overview
- 13 public-safe observations are available for this inspection.
- 13 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.
1 Feb 2016
21 CFR 211.101(c)
Weighing/measuring/subdividing supervision
Cited by Nancy M Espinal, Barbara J Wilimczyk-Macri
1 Feb 2016
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Nancy M Espinal, Barbara J Wilimczyk-Macri
1 Feb 2016
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Nancy M Espinal, Barbara J Wilimczyk-Macri
1 Feb 2016
21 CFR 211.160(b)(4)
Establishment of calibration procedures
Cited by Nancy M Espinal, Barbara J Wilimczyk-Macri
1 Feb 2016
21 CFR 211.186(b)(9)
Manufacturing Instructions and Specifications
Cited by Nancy M Espinal, Barbara J Wilimczyk-Macri
Inspected site
ADA.P. Deauville, LLCEaston, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.101(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.150(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | 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(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 13 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