Overview
- 12 public-safe observations are available for this inspection.
- 12 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.
13 Jun 2013
21 CFR 820.30(e)
Design review - Lack of or inadequate procedures
Cited by Catherine J Laufmann, Dawn M Braswell
13 Jun 2013
21 CFR 820.30(f)
Design verification - Lack of or inadequate procedures
Cited by Catherine J Laufmann, Dawn M Braswell
13 Jun 2013
21 CFR 820.30(g)
Design validation- Lack of or inadequate procedures
Cited by Catherine J Laufmann, Dawn M Braswell
13 Jun 2013
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Catherine J Laufmann, Dawn M Braswell
Inspected site
STSharplight TechnologiesRishon Le-Tsiyon, Israel
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1010.2(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(b) | 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(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 12 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