Protica, Inc. – FDA Inspection, Aug 27, 2012

Record Details

This FDA Inspection record concerns Protica, Inc., with an inspection on August 27, 2012, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company: Protica, Inc.
Inspection Date: August 27, 2012
Product Type: Food/cosmetics
Office: Center for Food Safety and Applied Nutrition

View Company Profile

ID · a32fd6a9-2d28-42ff-9b12-5c6ac561d0cc

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 796955
FDA center: Foods & Cosmetics
Project area: Foodborne Biological Hazards

FDA Citations

21 CFR 114.83Scheduled process establishment
21 CFR 114.100(c)Process deviations- identification and records
21 CFR 114.89Process deviation
21 CFR 113.89Process deviation identification
21 CFR 108.25(d)Reporting to FDA
21 CFR 108.25(c)(2)Process filing
21 CFR 113.83Scheduled processes not established
21 CFR 111.12Personnel - quality control personnel - qualified
21 CFR 111.83(a)Reserve sample - collect, hold
21 CFR 111.570(a)Records - product complaints: readily available

Showing 10 of 17 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Protica, Inc.

Date	Classification	Office	Project area
March 25, 2014	NAI	Center for Food Safety and Applied Nutrition	Food Composition, Standards, Labeling and Econ
November 6, 2013	VAI	Center for Food Safety and Applied Nutrition	Food Composition, Standards, Labeling and Econ
March 26, 2013	VAI	Center for Food Safety and Applied Nutrition	Foodborne Biological Hazards
October 6, 2011	OAI	Center for Food Safety and Applied Nutrition	Foodborne Biological Hazards
January 13, 2010	VAI	Center for Food Safety and Applied Nutrition	Food Composition, Standards, Labeling and Econ