FDA Inspection
Teratech CorporationTeratech Corporation – FDA Inspection, Aug 5, 2011
Record Details
This FDA Inspection record concerns Teratech Corporation, with an inspection on August 5, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Teratech Corporation
- Inspection Date
- August 5, 2011
- Product Type
- Devices
View Company Profile
ID · 80a34e97-c26c-481f-a8db-d3161da5dfbf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 740576
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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Other FDA inspections of Teratech Corporation
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 12, 2018 | Not classified | New England District Office | |
| August 28, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Teratech Corporation
- FDA Inspection 1081691 - 2018-04-12
- FDA Inspection 851968 - 2013-08-28
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