FDA Inspection
Isstormur ehfIsstormur ehf – FDA Inspection, Dec 7, 2023
Record Details
This FDA Inspection record concerns Isstormur ehf, with an inspection on December 7, 2023, issued by the Office of Inspections and Investigations.
- Company
- Isstormur ehf
- Inspection Date
- December 7, 2023
View Company Profile
ID · df0b80c4-4ff1-4fe8-8649-6745b9fc3ba6
Inspection Facts
- Inspection number
- 1224475
- FDA center
- Foods & Cosmetics
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 113.10Operators
- 21 CFR 113.100(a)Process records - forms missing information
- 21 CFR 113.100(a)(7)Other systems - records; critical factors
- 21 CFR 113.40(b)(1)TID accuracy test frequency
- 21 CFR 113.40(b)(2)(i)Scale, chart
- 21 CFR 113.40(b)(2)(iii)Unauthorized adjustment
- 21 CFR 113.40(j)Critical factors - frequency measured, recorded
- 21 CFR 113.60(d)Postprocess handling: equipment design, closure integrity
- 21 CFR 113.83Scheduled processes not established
- 21 CFR 113.87(c)Initial temperature of container contents
Showing 10 of 13 citations.
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.