Overview
- 28 public-safe observations are available for this inspection.
- 12 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.
5 Jan 2016
21 CFR 806.10(a)(1)
Report of risk to health
Cited by Miaja Umaedi, Samuel L Murray, Sayeeda Hdabe, Dawn M Braswell
5 Jan 2016
21 CFR 820.140
Lack of or inadequate procedures for handling
Cited by Miaja Umaedi, Samuel L Murray, Sayeeda Hdabe, Dawn M Braswell
5 Jan 2016
21 CFR 820.198(c)
Investigation of device failures
Cited by Miaja Umaedi, Samuel L Murray, Sayeeda Hdabe, Dawn M Braswell
5 Jan 2016
21 CFR 820.22
Quality audits - Lack of or inadequate procedures
Cited by Miaja Umaedi, Samuel L Murray, Sayeeda Hdabe, Dawn M Braswell
5 Jan 2016
21 CFR 820.25(a)
Personnel
Cited by Miaja Umaedi, Samuel L Murray, Sayeeda Hdabe, Dawn M Braswell
Inspected site
BIbioMerieux, Inc.Durham, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 806.10(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.140 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(g)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 28 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