FDA Inspection
Rhodia, Inc.Rhodia, Inc. – FDA Inspection, Jun 16, 2010
Record Details
This FDA Inspection record concerns Rhodia, Inc., with an inspection on June 16, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Rhodia, Inc.
- Inspection Date
- June 16, 2010
- Product Type
- Drugs
View Company Profile
ID · aeeef5b1-1d0a-4ada-b243-a5ef8a1354d0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 666371
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.194(a)(4)Data secured in course of each test
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.115(a)Reprocessing procedures lack steps to be taken
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.166(a)Lack of written stability program
Full citation text and observation details available on the Dashboard.
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.