Syntec Inc – FDA Inspection, Nov 3, 2010

Record Details

This FDA Inspection record concerns Syntec Inc, with an inspection on November 3, 2010, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company: Syntec Inc
Inspection Date: November 3, 2010
Product Type: Food/cosmetics
Office: Center for Food Safety and Applied Nutrition

View Company Profile

ID · ae2f4b8c-7e09-4383-998b-04ae6310ac4b

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 697068
FDA center: Foods & Cosmetics
Project area: Food Composition, Standards, Labeling and Econ

FDA Citations

21 CFR 111.12Personnel - quality control personnel - qualified
21 CFR 111.410(b)Labels - issuance, use
21 CFR 111.70(b)(1)Specifications - component identity
21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
21 CFR 111.70(e)Specifications - identity, purity, strength, composition
21 CFR 111.25(a)Procedures - calibrating instruments
21 CFR 111.140(b)(1)Records - quality control operations; responsibilities
21 CFR 111.140(b)(1)QC ops; written procedures; material review, disposition
21 CFR 111.570(b)(1)Written procedures - product complaint; review, investigate
21 CFR 111.255(a)Batch record - every batch

Showing 10 of 11 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Syntec Inc

Date	Classification	Office	Project area
September 20, 2011	OAI	Center for Food Safety and Applied Nutrition	Food Composition, Standards, Labeling and Econ
June 17, 2011	OAI	Center for Food Safety and Applied Nutrition	Food Composition, Standards, Labeling and Econ