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FDA Inspection
•Scilabs Pharmaceuticals•February 4, 2014

Scilabs Pharmaceuticals – FDA Inspection, Feb 4, 2014

Record Details

This FDA Inspection record concerns Scilabs Pharmaceuticals, with an inspection on February 4, 2014, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Scilabs Pharmaceuticals
Inspection Date
February 4, 2014
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
View Company Profile

ID · f6e7f2fb-7bef-40a9-bd98-48e9184aba28

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number
863721
FDA center
Foods & Cosmetics
Project area
Food Composition, Standards, Labeling and Econ

FDA Citations

7
  1. 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
  2. 21 CFR 111.70(a)Specifications - manufacturing process
  3. 21 CFR 111.103Written procedures - quality control operations
  4. 21 CFR 111.35(b)(2)Document-equipment date of use, maintain, clean, sanitize
  5. 21 CFR 111.205(a)Master manufacturing record - each batch
  6. 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
  7. 21 CFR 111.255(b)Batch record - complete

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Scilabs Pharmaceuticals

2
DateClassificationOfficeProject area
October 25, 2013OAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
August 14, 2012OAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
Other documents for Scilabs Pharmaceuticals
  • FDA Inspection 853965 - 2013-10-25
  • FDA Inspection 795622 - 2012-08-14

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