FDA Inspection
RPh Concepts LLCRPh Concepts LLC – FDA Inspection, Jun 23, 2011
Record Details
This FDA Inspection record concerns RPh Concepts LLC, with an inspection on June 23, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- RPh Concepts LLC
- Inspection Date
- June 23, 2011
- Product Type
- Drugs
View Company Profile
ID · 69ed1844-12dd-45cd-b067-fce1b886eeeb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 723489
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 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 211.68(a)Calibration/Inspection/Checking not done
- 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
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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 |
| April 16, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for RPh Concepts LLC
- FDA Inspection 785673 - 2012-06-07
- FDA Inspection 576190 - 2009-04-16
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.