Overview
- 6 public-safe observations are available for this inspection.
- 6 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.
3 Aug 2011
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Leo J Lagrotte, Melanie G Warzala
3 Aug 2011
21 CFR 820.50(a)(3)
Acceptable supplier records, inadequate records
Cited by Leo J Lagrotte, Melanie G Warzala
3 Aug 2011
21 CFR 820.75(a)
Lack of or inadequate process validation
Cited by Leo J Lagrotte, Melanie G Warzala
Inspected site
BRBenz Research And Development CorporationSarasota, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(e) | 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