FDA Inspection
Fisher Wallace Laboratories Inc.Fisher Wallace Laboratories Inc. – FDA Inspection, Dec 20, 2012
Record Details
This FDA Inspection record concerns Fisher Wallace Laboratories Inc., with an inspection on December 20, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 20, 2012
- Product Type
- Devices
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ID · cbbda4fa-0429-4634-9d72-7427ec7dfd82
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 812027
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(j)Design history file
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Fisher Wallace Laboratories Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| May 13, 2025 | VAI | New York District Office | Compliance: Medical Devices |
| March 15, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 25, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 1, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 6, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Fisher Wallace Laboratories Inc.
- FDA Inspection 1269731 - 2025-05-13
- FDA Inspection 1199962 - 2023-03-15
- FDA Inspection 1141346 - 2019-06-25
- FDA Inspection 969525 - 2016-03-01
- FDA Inspection 909300 - 2015-01-06
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