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FDA Inspection
•Schlotterbeck & Foss, LLC•June 4, 2019

Schlotterbeck & Foss, LLC – FDA Inspection, Jun 4, 2019

Record Details

This FDA Inspection record concerns Schlotterbeck & Foss, LLC, with an inspection on June 4, 2019, issued by the Center for Veterinary Medicine, covering veterinary.

Company
Schlotterbeck & Foss, LLC
Inspection Date
June 4, 2019
Product Type
Veterinary
Office
Center for Veterinary Medicine
Person
  • Robert J. Martin
View Company Profile

ID · ea71f7b9-5ac2-48a3-8128-c2ac20f11c27

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1091897
FDA center
Animal Drugs & Feeds
Project area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Outcome
Form 483 issued

FDA Citations

9
  1. 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
  2. 21 CFR 211.84(d)(1)Component identity verification
  3. 21 CFR 211.84(d)(6)Objectionable microbiological contamination
  4. 21 CFR 211.25(a)Training--operations, GMPs, written procedures
  5. 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
  6. 21 CFR 211.110(b)In-process materials specifications
  7. 21 CFR 211.186(b)(7)Theoretical Yield and Percentages
  8. 21 CFR 211.100(a)Absence of Written Procedures
  9. 21 CFR 211.192Investigations of discrepancies, failures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Schlotterbeck & Foss, LLC

7
DateClassificationOfficeProject area
May 5, 2026NAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
December 23, 2021NAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
December 18, 2017VAICenter for Veterinary MedicineMonitoring of Marketed Animal Drugs, Feed, and Devices
September 18, 2017NAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
January 14, 2014NAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
View all 7 other inspections on the company page
Other documents for Schlotterbeck & Foss, LLC
  • FDA Inspection 1312596 - 2026-05-05
  • FDA Inspection 1160046 - 2021-12-23
  • FDA Inspection 1035357 - 2017-12-18
  • FDA Inspection 1027145 - 2017-09-18
  • FDA Inspection 866837 - 2014-01-14

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Contact
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
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