FDA Inspection
Wisconsin Pharmacal CompanyWisconsin Pharmacal Company – FDA Inspection, Jul 11, 2012
Record Details
This FDA Inspection record concerns Wisconsin Pharmacal Company, with an inspection on July 11, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Wisconsin Pharmacal Company
- Inspection Date
- July 11, 2012
- Product Type
- Devices
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ID · e2823435-4b29-4fdf-8316-2307479b4f83
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 790948
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
14- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 820.100(b)Documentation
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.165(e)Test methods
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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 |
| November 12, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 855526 - 2013-11-12
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