FDA Inspection
Ocenco, IncorporatedOcenco, Incorporated – FDA Inspection, Apr 20, 2012
Record Details
This FDA Inspection record concerns Ocenco, Incorporated, with an inspection on April 20, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ocenco, Incorporated
- Inspection Date
- April 20, 2012
- Product Type
- Devices
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ID · 5ee520bc-35bc-4308-a91c-81dfbe9d2153
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 780454
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
- 21 CFR 820.50(b)Supplier notification of changes
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Other FDA inspections of Ocenco, Incorporated
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 11, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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