FDA Inspection
Seirin-america, Inc.Seirin-america, Inc. – FDA Inspection, Mar 18, 2010
Record Details
This FDA Inspection record concerns Seirin-america, Inc., with an inspection on March 18, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Seirin-america, Inc.
- Inspection Date
- March 18, 2010
- Product Type
- Devices
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ID · 7540c484-950c-4428-8bcf-c83fa6b67347
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 652313
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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