FDA Inspection
PETNET Solutions, IncPETNET Solutions, Inc – FDA Inspection, Sep 8, 2023
Record Details
This FDA Inspection record concerns PETNET Solutions, Inc, with an inspection on September 8, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 5085b1db-bcac-4865-813b-b9ba3d8fe11a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1217209
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 212.71(a)Non-Conforming Product Investigation Incomplete
- 21 CFR 212.30(b)Equipment procedures
- 21 CFR 212.30(a)Orderly handling, prevention of mix-ups, prevention of contamination
- 21 CFR 212.30(a)Orderly handling, prevention of mix-ups, prevention of contamination
- 21 CFR 212.30(b)Equipment procedures
- 21 CFR 212.71(a)Non-Conforming Product Investigation Incomplete
Full citation text and observation details available on the Dashboard.
Other FDA inspections of PETNET Solutions, Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 19, 2022 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 21, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 13, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for PETNET Solutions, Inc
- FDA Inspection 1179095 - 2022-08-19
- FDA Inspection 945771 - 2015-10-21
- FDA Inspection 798542 - 2012-09-13
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.