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FDA Inspection
•Rose Laboratories, Inc.•December 1, 2010

Rose Laboratories, Inc. – FDA Inspection, Dec 1, 2010

Record Details

This FDA Inspection record concerns Rose Laboratories, Inc., with an inspection on December 1, 2010, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Rose Laboratories, Inc.
Inspection Date
December 1, 2010
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
View Company Profile

ID · f2b9987d-f21e-43f1-b099-23bf1ea852a3

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
702207
FDA center
Foods & Cosmetics
Project area
Colors and Cosmetics Technology

FDA Citations

13
  1. 21 CFR 211.160(a)Deviations from laboratory control requirements
  2. 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
  3. 21 CFR 211.25(a)GMP Training Frequency
  4. 21 CFR 211.34Consultant Records
  5. 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
  6. 21 CFR 211.84(d)(1)Identity Testing of Each Component
  7. 21 CFR 211.22(c)Approve or reject procedures or specs
  8. 21 CFR 211.100(a)Absence of Written Procedures
  9. 21 CFR 211.182Dedicated equipment: records part of batch record
  10. 21 CFR 211.22(d)Procedures not in writing, fully followed

Showing 10 of 13 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Rose Laboratories, Inc.

1
DateClassificationOfficeProject area
June 4, 2013NAICenter for Food Safety and Applied NutritionColors and Cosmetics Technology
Other documents for Rose Laboratories, Inc.
  • FDA Inspection 834102 - 2013-06-04

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