Overview
- 7 public-safe observations are available for this inspection.
- 7 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
27 Mar 2014
21 CFR 803.17(a)(1)
Lack of System for Event Evaluations
Cited by Catherine J Laufmann, Dorothy W Lee
27 Mar 2014
21 CFR 820.20(c)
Management review - Lack of or inadequate procedures
Cited by Catherine J Laufmann, Dorothy W Lee
27 Mar 2014
21 CFR 820.22
Quality audits - Lack of or inadequate procedures
Cited by Catherine J Laufmann, Dorothy W Lee
27 Mar 2014
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Catherine J Laufmann, Dorothy W Lee
27 Mar 2014
21 CFR 820.75(a)
Lack of or inadequate process validation
Cited by Catherine J Laufmann, Dorothy W Lee
Inspected site
MLMedinol Ltd.Jerusalem, Israel
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.17(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 7 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