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FDA Inspection
•Scilabs Pharmaceuticals•August 14, 2012

Scilabs Pharmaceuticals – FDA Inspection, Aug 14, 2012

Record Details

This FDA Inspection record concerns Scilabs Pharmaceuticals, with an inspection on August 14, 2012, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Scilabs Pharmaceuticals
Inspection Date
August 14, 2012
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
View Company Profile

ID · 9ec2aa47-ed98-4726-b41f-e1a91c7cc70a

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
795622
FDA center
Foods & Cosmetics
Project area
Food Composition, Standards, Labeling and Econ

FDA Citations

10
  1. 21 CFR 111.12(c)Personnel - education, training, experience
  2. 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
  3. 21 CFR 111.75(a)(2)Component - confirm identity; specifications met
  4. 21 CFR 111.353Manufacturing operations - written procedures
  5. 21 CFR 111.103Written procedures - quality control operations
  6. 21 CFR 111.15(a)(1)Grounds - equipment, litter, weeds
  7. 21 CFR 111.15(c)(1)Cleaning compounds
  8. 21 CFR 111.75(c)Specifications met - verify; finished batch
  9. 21 CFR 111.255(b)Batch record - complete
  10. 21 CFR 111.20(b)Physical plant - space; equipment, materials

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Scilabs Pharmaceuticals

2
DateClassificationOfficeProject area
February 4, 2014OAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
October 25, 2013OAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
Other documents for Scilabs Pharmaceuticals
  • FDA Inspection 863721 - 2014-02-04
  • FDA Inspection 853965 - 2013-10-25

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