Overview
- 10 public-safe observations are available for this inspection.
- 10 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.
12 May 2009
21 CFR 820.20(e)
Quality System Procedures
Cited by Claudette D Brooks, Gamal A Norton, Melanie M Walker, Derek C Price
12 May 2009
21 CFR 820.30(b)
Design plans - Lack of or inadequate
Cited by Claudette D Brooks, Gamal A Norton, Melanie M Walker, Derek C Price
12 May 2009
21 CFR 820.70(a)(1)
Process control instructions
Cited by Claudette D Brooks, Gamal A Norton, Melanie M Walker, Derek C Price
12 May 2009
21 CFR 820.70(c)
Environmental control Lack of or inadequate procedures
Cited by Claudette D Brooks, Gamal A Norton, Melanie M Walker, Derek C Price
12 May 2009
21 CFR 820.90(b)(1)
Documentation of disposition, justification, signature
Cited by Claudette D Brooks, Gamal A Norton, Melanie M Walker, Derek C Price
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 820.100(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 10 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