FDA Inspection
RPh Concepts LLCRPh Concepts LLC – FDA Inspection, Apr 16, 2009
Record Details
This FDA Inspection record concerns RPh Concepts LLC, with an inspection on April 16, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- RPh Concepts LLC
- Inspection Date
- April 16, 2009
- Product Type
- Drugs
View Company Profile
ID · acde4da5-d10f-4dfa-9213-903c98b14241
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 576190
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.184(b)Component Test Records
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.22(a)Lack of quality control unit
Full citation text and observation details available on the Dashboard.
Other FDA inspections of RPh Concepts LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 7, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 23, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for RPh Concepts LLC
- FDA Inspection 785673 - 2012-06-07
- FDA Inspection 723489 - 2011-06-23
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.