FDA Inspection
DUSA Pharmaceuticals, Inc.DUSA Pharmaceuticals, Inc. – FDA Inspection, Sep 8, 2023
Record Details
This FDA Inspection record concerns DUSA Pharmaceuticals, Inc., with an inspection on September 8, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 473e61bf-5426-48c4-a8a0-9785e8266127
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1217179
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of DUSA Pharmaceuticals, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 22, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 29, 2015 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| June 20, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 18, 2012 | NAI | Center for Drug Evaluation and Research | Postmarket Surv. and Epidemiology |
| March 4, 2010 | NAI | Center for Drug Evaluation and Research | Postmarket Surv. and Epidemiology |
Other documents for DUSA Pharmaceuticals, Inc.
- FDA Inspection 986674 - 2016-09-22
- FDA Inspection 934706 - 2015-05-29
- FDA Inspection 788414 - 2012-06-20
- FDA Inspection 777605 - 2012-04-18
- FDA Inspection 649444 - 2010-03-04
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