FDA Inspection
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare companyInsight Pharmaceuticals LLC, a Prestige Consumer Healthcare company – FDA Inspection, Aug 24, 2015
Record Details
This FDA Inspection record concerns Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company, with an inspection on August 24, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 24, 2015
- Product Type
- Devices
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ID · 96003acb-9eea-4a05-8eb4-1c49d746e187
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 945648
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
6| Date | Classification | Office | Project area |
|---|---|---|---|
| October 18, 2022 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| May 10, 2018 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| April 27, 2018 | Not classified | New York District Office | |
| May 13, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 6, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
- FDA Inspection 1181795 - 2022-10-18
- FDA Inspection 1053169 - 2018-05-10
- FDA Inspection 1079257 - 2018-04-27
- FDA Inspection 832327 - 2013-05-13
- FDA Inspection 824146 - 2013-03-06
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