Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
2 Jul 2009
21 CFR 110.40(d)
Holding, conveying, mfg systems - design & construction
Cited by Scott T Ballard, Tricia S Martinez
2 Jul 2009
21 CFR 113.60(a)(1)
Closure examinations - corrective actions taken and recorded
Cited by Scott T Ballard, Tricia S Martinez
2 Jul 2009
21 CFR 113.100(a)
Process records - forms missing information
Cited by Scott T Ballard, Tricia S Martinez
Inspected site
DADurrset Amigos Ltd.San Antonio, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.60(a)(1) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 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