Overview
- 7 public-safe observations are available for this inspection.
- 7 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
15 Nov 2012
21 CFR 820.30(d)
Design output - Lack of or inadequate procedures
Cited by Melissa I Michurski
15 Nov 2012
21 CFR 820.30(e)
Design review - Lack of or inadequate procedures
Cited by Melissa I Michurski
15 Nov 2012
21 CFR 820.30(f)
Design verification - Lack of or inadequate procedures
Cited by Melissa I Michurski
15 Nov 2012
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Melissa I Michurski
Inspected site
MGMueller-Omicron GmbH & Co. KGLindlar, Germany
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 820.30(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | 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 7 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