FDA Inspection
Wisconsin Pharmacal CompanyWisconsin Pharmacal Company – FDA Inspection, Nov 12, 2013
Record Details
This FDA Inspection record concerns Wisconsin Pharmacal Company, with an inspection on November 12, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Wisconsin Pharmacal Company
- Inspection Date
- November 12, 2013
- Product Type
- Devices
View Company Profile
ID · e7a29e6f-f0e1-4a78-98c0-2f109b9318ec
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 855526
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
14- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 211.165(e)Test methods
Showing 10 of 14 citations.
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Other FDA inspections of Wisconsin Pharmacal Company
7| Date | Classification | Office | Project area |
|---|---|---|---|
| March 7, 2025 | Not classified | Minneapolis District Office | |
| February 12, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 13, 2018 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 4, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 11, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Wisconsin Pharmacal Company
- FDA Inspection 1265728 - 2025-03-07
- FDA Inspection 1082774 - 2019-02-12
- FDA Inspection 1042587 - 2018-02-13
- FDA Inspection 944943 - 2015-09-04
- FDA Inspection 790948 - 2012-07-11
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