FDA Inspection
Levlad, LLCLevlad, LLC – FDA Inspection, Sep 9, 2010
Record Details
This FDA Inspection record concerns Levlad, LLC, with an inspection on September 9, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Levlad, LLC
- Inspection Date
- September 9, 2010
- Product Type
- Drugs
View Company Profile
ID · c8d88561-a917-441a-b117-a59846c34cb9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 679474
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
14- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.122(a)Sampling/testing of labeling/packaging materials
- 21 CFR 211.186(b)(8)Description of containers, labels, et. al.
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.186(b)(7)Theoretical Yield and Percentages
- 21 CFR 211.186(b)(1)Name, strength, dosage form
- 21 CFR 211.100(a)Absence of Written Procedures
Showing 10 of 14 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Levlad, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| May 19, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 17, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 12, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 13, 2012 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| June 17, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Levlad, LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.