FDA Inspection
Raf LLCRaf LLC – FDA Inspection, Dec 5, 2008
Record Details
This FDA Inspection record concerns Raf LLC, with an inspection on December 5, 2008, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Raf LLC
- Inspection Date
- December 5, 2008
- Product Type
- Drugs
View Company Profile
ID · c8d59119-d739-405f-9478-36bf6d245e13
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 559692
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
22- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.188(b)(9)Description of containers and closures
- 21 CFR 211.188(b)(10)Records of any sampling performed
- 21 CFR 211.188(b)(2)Identity of major equipment and lines used
- 21 CFR 211.80(d)Status of Each Lot Identified
- 21 CFR 211.160(b)(2)In-process materials - sampling, testing procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(1)Sample identification and other information
- 21 CFR 211.194(a)(2)Statement of methods and data
- 21 CFR 211.194(d)Laboratory equipment calibration records
Showing 10 of 22 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Raf LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 12, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 18, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Raf LLC
- FDA Inspection 988661 - 2016-02-12
- FDA Inspection 872046 - 2014-03-18
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.