FDA Inspection
Batrik Medical Mfg., Inc.Batrik Medical Mfg., Inc. – FDA Inspection, Jun 27, 2013
Record Details
This FDA Inspection record concerns Batrik Medical Mfg., Inc., with an inspection on June 27, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Batrik Medical Mfg., Inc.
- Inspection Date
- June 27, 2013
- Product Type
- Devices
View Company Profile
ID · 9a4ed98a-f308-4b17-850b-fabe00e68dce
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 839303
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.70(f)Buildings
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.184DHR content
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Other FDA inspections of Batrik Medical Mfg., Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 16, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Batrik Medical Mfg., Inc.
- FDA Inspection 934636 - 2015-07-16
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