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FDA Inspection
•Levlad, LLC•July 12, 2013

Levlad, LLC – FDA Inspection, Jul 12, 2013

Record Details

This FDA Inspection record concerns Levlad, LLC, with an inspection on July 12, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Levlad, LLC
Inspection Date
July 12, 2013
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · a151be2b-02d6-4ce8-bd6d-7a8c0a246594

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
839430
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

5
  1. 21 CFR 211.180(b)Record maintenance 1 year (except exempt OTC)
  2. 21 CFR 211.28(b)Habits of good sanitation & health
  3. 21 CFR 211.192Investigations of discrepancies, failures
  4. 21 CFR 211.67(b)Written procedures not established/followed
  5. 21 CFR 211.100(b)SOPs not followed / documented

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Levlad, LLC

6
DateClassificationOfficeProject area
May 19, 2022VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
August 17, 2016NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
July 13, 2012VAICenter for Food Safety and Applied NutritionColors and Cosmetics Technology
June 17, 2011VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
September 9, 2010VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 6 other inspections on the company page
Other documents for Levlad, LLC
  • FDA Inspection 1171243 - 2022-05-19
  • FDA Inspection 986874 - 2016-08-17
  • FDA Inspection 791322 - 2012-07-13
  • FDA Inspection 732385 - 2011-06-17
  • FDA Inspection 679474 - 2010-09-09

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