FDA Inspection
Syntron Bioresearch IncSyntron Bioresearch Inc – FDA Inspection, Jan 21, 2010
Record Details
This FDA Inspection record concerns Syntron Bioresearch Inc, with an inspection on January 21, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Syntron Bioresearch Inc
- Inspection Date
- January 21, 2010
- Product Type
- Devices
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ID · b4a2af1c-e7fc-4208-9270-0a1947b87be0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 641653
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.80(e)Documentation
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.25(b)Training records
- 21 CFR 820.150(a)Storage procedures to prevent mix-ups
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling plans
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Other FDA inspections of Syntron Bioresearch Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 2, 2025 | NAI | Los Angeles District Office | Postmarket Assurance: Medical Devices |
| October 14, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 15, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 1, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 30, 2010 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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