FDA Inspection
Schlotterbeck & Foss, LLCSchlotterbeck & Foss, LLC – FDA Inspection, Dec 18, 2017
Record Details
This FDA Inspection record concerns Schlotterbeck & Foss, LLC, with an inspection on December 18, 2017, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · 60fc706e-6a19-4865-8197-cb7b4603b694
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1035357
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 211.87Retest of approved components/containers/closures
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.101(d)Component addition checked by 2nd person
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.184(a)Record information required
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.166(a)Lack of written stability program
Showing 10 of 11 citations.
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Other FDA inspections of Schlotterbeck & Foss, LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| May 5, 2026 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| December 23, 2021 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| June 4, 2019 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| September 18, 2017 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| January 14, 2014 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for Schlotterbeck & Foss, LLC
- FDA Inspection 1312596 - 2026-05-05
- FDA Inspection 1160046 - 2021-12-23
- FDA Inspection 1091897 - 2019-06-04
- FDA Inspection 1027145 - 2017-09-18
- FDA Inspection 866837 - 2014-01-14
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