Overview
- 8 public-safe observations are available for this inspection.
- 7 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.
17 May 2012
21 CFR 806.10(a)(1)
Report of risk to health
Cited by Shafiq Ahadi, Steven D Kehoe, Mary K Concannon, Matthew H Hunt
17 May 2012
21 CFR 820.40(a)
Not approved or obsolete document retrieval
Cited by Shafiq Ahadi, Steven D Kehoe, Mary K Concannon, Matthew H Hunt
17 May 2012
21 CFR 820.90(a)
Nonconforming product control
Cited by Shafiq Ahadi, Steven D Kehoe, Mary K Concannon, Matthew H Hunt
17 May 2012
21 CFR 820.90(a)
Nonconforming product, Lack of or inadequate procedures
Cited by Shafiq Ahadi, Steven D Kehoe, Mary K Concannon, Matthew H Hunt
17 May 2012
21 CFR 820.90(b)(1)
Procedures for product review,disposition lack of/inadequate
Cited by Shafiq Ahadi, Steven D Kehoe, Mary K Concannon, Matthew H Hunt
Inspected site
B&Bausch & Lomb IncSaint Louis, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 806.10(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 8 observations
The source PDF and 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