FDA Inspection
Polysciences, Inc.Polysciences, Inc. – FDA Inspection, Mar 12, 2019
Record Details
This FDA Inspection record concerns Polysciences, Inc., with an inspection on March 12, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 140c6a85-854f-4f9f-91f8-fc00be1204da
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1082540
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.182Written records kept in individual logs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Polysciences, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 29, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 24, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Polysciences, Inc.
- FDA Inspection 924102 - 2015-04-29
- FDA Inspection 668660 - 2010-06-24
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.