Overview
- 12 public-safe observations are available for this inspection.
- 11 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
25 Jun 2010
21 CFR 820.20(c)
Management review - defined interval, sufficient frequency
Cited by Claudette D Brooks, Trang N Cox, Tammara A Stephens, Ibad U Khan
25 Jun 2010
21 CFR 820.22
Quality Audits - defined intervals
Cited by Claudette D Brooks, Trang N Cox, Tammara A Stephens, Ibad U Khan
25 Jun 2010
21 CFR 820.25(b)
Training records
Cited by Claudette D Brooks, Trang N Cox, Tammara A Stephens, Ibad U Khan
25 Jun 2010
21 CFR 820.30(b)
Design plans - Lack of or inadequate
Cited by Claudette D Brooks, Trang N Cox, Tammara A Stephens, Ibad U Khan
25 Jun 2010
21 CFR 820.60
Identification procedures, Lack of or inadequate procedures
Cited by Claudette D Brooks, Trang N Cox, Tammara A Stephens, Ibad U Khan
Inspected site
B&Bausch & Lomb IncorporatedGreenville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.60 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.86 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 12 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