Overview
- 9 public-safe observations are available for this inspection.
- 9 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.
30 Jul 2014
21 CFR 820.30(h)
Design transfer - Lack of or inadequate procedures
Cited by Shafiq Ahadi, Eric M Padgett, Edward E Lockwood, Sean T Creighton
30 Jul 2014
21 CFR 820.72(a)
Calibration, Inspection, etc. Procedures Lack of or Inadequ
Cited by Shafiq Ahadi, Eric M Padgett, Edward E Lockwood, Sean T Creighton
30 Jul 2014
21 CFR 820.75(c)
Process changes - review, evaluation and revalidation
Cited by Shafiq Ahadi, Eric M Padgett, Edward E Lockwood, Sean T Creighton
30 Jul 2014
21 CFR 820.90(a)
Nonconforming product control
Cited by Shafiq Ahadi, Eric M Padgett, Edward E Lockwood, Sean T Creighton
30 Jul 2014
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Shafiq Ahadi, Eric M Padgett, Edward E Lockwood, Sean T Creighton
Inspected site
BIBiomerieux IncHazelwood, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | 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(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.200(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | 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 9 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