Overview
- 6 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
22 Oct 2013
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Ileana Barreto-Pettit, Juanita P Versace, Karen E Dorazio
22 Oct 2013
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Ileana Barreto-Pettit, Juanita P Versace, Karen E Dorazio
22 Oct 2013
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Ileana Barreto-Pettit, Juanita P Versace, Karen E Dorazio
22 Oct 2013
21 CFR 211.186(b)(7)
Theoretical yield statement including percentages
Cited by Ileana Barreto-Pettit, Juanita P Versace, Karen E Dorazio
22 Oct 2013
21 CFR 211.192
Extent of discrepancy, failure investigations
Cited by Ileana Barreto-Pettit, Juanita P Versace, Karen E Dorazio
Inspected site
DBDelpharm Boucherville Canada Inc.Boucherville, Canada
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 | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 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