FDA Inspection
PRC Ticinum Lab, S.R.L.PRC Ticinum Lab, S.R.L. – FDA Inspection, May 9, 2018
Record Details
This FDA Inspection record concerns PRC Ticinum Lab, S.R.L., with an inspection on May 9, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 05ae745d-9ca0-4e5a-889f-34328d204731
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1051225
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.194(a)(2)Laboratory Test Method Verification
- 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 PRC Ticinum Lab, S.R.L.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 27, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 31, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 2, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 13, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for PRC Ticinum Lab, S.R.L.
- FDA Inspection 1270124 - 2023-10-27
- FDA Inspection 1128396 - 2019-05-31
- FDA Inspection 872194 - 2014-04-02
- FDA Inspection 735986 - 2011-07-13
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.