FDA Inspection
Raf LLCRaf LLC – FDA Inspection, Feb 12, 2016
Record Details
This FDA Inspection record concerns Raf LLC, with an inspection on February 12, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Raf LLC
- Inspection Date
- February 12, 2016
- Product Type
- Drugs
View Company Profile
ID · 43559781-d927-4129-ab93-9d4bdcae1716
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 988661
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.188(b)(9)Description of containers and closures
- 21 CFR 211.160(b)(2)Acceptance of in-process materials
- 21 CFR 211.130(d)Examination of packaging and labeling
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.67(b)(3)Cleaning SOPs/instructions
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.84(c)(4)Top/Middle/Bottom container sampling
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.48(a)Potable water standards not met
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Raf LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 18, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 5, 2008 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Raf LLC
- FDA Inspection 872046 - 2014-03-18
- FDA Inspection 559692 - 2008-12-05
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