Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
4 Jul 2014
21 CFR 211.68(b)
Computer control of master formula records
Cited by Michael H Tollon, Kim L Thomas Cruse
4 Jul 2014
21 CFR 211.160(b)(3)
Drug products-sampling procedures/specifications
Cited by Michael H Tollon, Kim L Thomas Cruse
4 Jul 2014
21 CFR 211.160(b)(4)
Establishment of calibration procedures
Cited by Michael H Tollon, Kim L Thomas Cruse
4 Jul 2014
21 CFR 211.166(a)
Lack of written stability program
Cited by Michael H Tollon, Kim L Thomas Cruse
4 Jul 2014
21 CFR 211.194(c)
Testing and standardization of standards et. al.
Cited by Michael H Tollon, Kim L Thomas Cruse
Inspected site
DMDouglas Manufacturing LimitedAuckland, New Zealand
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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