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FDA Inspection
•Syntec Inc•September 20, 2011

Syntec Inc – FDA Inspection, Sep 20, 2011

Record Details

This FDA Inspection record concerns Syntec Inc, with an inspection on September 20, 2011, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Syntec Inc
Inspection Date
September 20, 2011
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
View Company Profile

ID · e684b336-89c3-4fed-a8fe-f1d6a5c98377

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number
745866
FDA center
Foods & Cosmetics
Project area
Food Composition, Standards, Labeling and Econ

FDA Citations

7
  1. 21 CFR 111.70(b)(1)Specifications - component identity
  2. 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
  3. 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
  4. 21 CFR 111.140(b)(1)QC ops; written procedures; material review, disposition
  5. 21 CFR 111.255(a)Batch record - every batch
  6. 21 CFR 111.205(a)Master manufacturing record - each batch
  7. 21 CFR 111.77(a)Specifications not met - reject, quality control

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Syntec Inc

2
DateClassificationOfficeProject area
June 17, 2011OAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
November 3, 2010OAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
Other documents for Syntec Inc
  • FDA Inspection 730923 - 2011-06-17
  • FDA Inspection 697068 - 2010-11-03

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