FDA Inspection
Eastwestmed, Inc.Eastwestmed, Inc. – FDA Inspection, Aug 10, 2011
Record Details
This FDA Inspection record concerns Eastwestmed, Inc., with an inspection on August 10, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Eastwestmed, Inc.
- Inspection Date
- August 10, 2011
- Product Type
- Devices
View Company Profile
ID · a3635d56-b86b-44c3-bfef-255d1ea9a108
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 738479
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.50(a)(2)Supplier oversight
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Eastwestmed, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 3, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Eastwestmed, Inc.
- FDA Inspection 1059384 - 2018-07-03
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