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FDA Inspection
•ChemRite CoPac LLC•March 24, 2016

ChemRite CoPac LLC – FDA Inspection, Mar 24, 2016

Record Details

This FDA Inspection record concerns ChemRite CoPac LLC, with an inspection on March 24, 2016, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
ChemRite CoPac LLC
Inspection Date
March 24, 2016
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
View Company Profile

ID · 8b70c030-3faf-4588-a935-a3d2235f3da0

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
971375
FDA center
Foods & Cosmetics
Project area
Colors and Cosmetics Technology

FDA Citations

6
  1. 21 CFR 211.194(a)Complete test data included in records
  2. 21 CFR 211.113(a)Procedures for non-sterile drug products
  3. 21 CFR 211.67(b)(3)Cleaning SOPs/instructions
  4. 21 CFR 211.22(c)Approve or reject procedures or specs
  5. 21 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs
  6. 21 CFR 211.67(b)Written procedures not established/followed

Full citation text and observation details available on the Dashboard.

Other FDA inspections of ChemRite CoPac LLC

6
DateClassificationOfficeProject area
September 18, 2026Not classifiedMinneapolis District OfficeDrug Quality Assurance
April 11, 2023VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
July 15, 2016OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
February 21, 2013VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
November 21, 2011VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 6 other inspections on the company page
Other documents for ChemRite CoPac LLC
  • FDA Inspection 1336320 - 2026-09-18
  • FDA Inspection 1204584 - 2023-04-11
  • FDA Inspection 987532 - 2016-07-15
  • FDA Inspection 820373 - 2013-02-21
  • FDA Inspection 756820 - 2011-11-21

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