FDA Inspection
Ocenco, IncorporatedOcenco, Incorporated – FDA Inspection, Mar 11, 2010
Record Details
This FDA Inspection record concerns Ocenco, Incorporated, with an inspection on March 11, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Ocenco, Incorporated
- Inspection Date
- March 11, 2010
- Product Type
- Drugs
View Company Profile
ID · a532cbe6-f535-49c6-9b39-8df76d11e2cf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 652468
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 820.90(b)(2)Retesting and reevaluation of reworked product
- 21 CFR 820.100(a)(1)Procedure for analysis of data sources
- 21 CFR 820.90(b)(1)Documentation of disposition, justification, signature
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Other FDA inspections of Ocenco, Incorporated
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 20, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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