FDA Inspection
Istituto De Angeli SrlIstituto De Angeli Srl – FDA Inspection, Oct 31, 2014
Record Details
This FDA Inspection record concerns Istituto De Angeli Srl, with an inspection on October 31, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Istituto De Angeli Srl
- Inspection Date
- October 31, 2014
- Product Type
- Drugs
View Company Profile
ID · c3de8029-a96d-40fb-9516-de2d516e1949
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 901969
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.180(e)(2)Review of problem drugs
- 21 CFR 211.160(b)(1)Sampling and testing procedures described
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Istituto De Angeli Srl
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 15, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 24, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Istituto De Angeli Srl
- FDA Inspection 1215860 - 2022-07-15
- FDA Inspection 1092771 - 2018-01-24
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.