Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
5 Sep 2013
21 CFR 111.465(a)(1)
Hold - reserve samples; ordinary storage
Cited by Ricardo Reyes Deleon, Mary M Finn
5 Sep 2013
21 CFR 111.465(a)(2)
Hold - reserve sample; closure system
Cited by Ricardo Reyes Deleon, Mary M Finn
Inspected site
BBBLT BERG LipidTech. ASEidsnes, Norway
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.37(e)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.465(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.465(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.11(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 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