FDA Inspection
Ther-RX CorporationTher-RX Corporation – FDA Inspection, Feb 11, 2011
Record Details
This FDA Inspection record concerns Ther-RX Corporation, with an inspection on February 11, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Ther-RX Corporation
- Inspection Date
- February 11, 2011
- Product Type
- Drugs
View Company Profile
ID · 2deb925f-03e9-4dc2-af8f-4cb3195a5707
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 709497
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Ther-RX Corporation
5| Date | Classification | Office | Project area |
|---|---|---|---|
| February 26, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 22, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 11, 2011 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| August 20, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 2, 2009 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Ther-RX Corporation
- FDA Inspection 915593 - 2015-02-26
- FDA Inspection 829562 - 2013-02-22
- FDA Inspection 714035 - 2011-03-11
- FDA Inspection 677252 - 2010-08-20
- FDA Inspection 554861 - 2009-02-02
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