FDA Inspection
Hightech American Industrial Laboratories, Inc.Hightech American Industrial Laboratories, Inc. – FDA Inspection, May 27, 2010
Record Details
This FDA Inspection record concerns Hightech American Industrial Laboratories, Inc., with an inspection on May 27, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 27, 2010
- Product Type
- Devices
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ID · 9d874781-89f2-4d3a-b55e-2237551f6376
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 663897
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.50(a)(3)Acceptable supplier records
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Hightech American Industrial Laboratories, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 25, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 25, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 22, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Hightech American Industrial Laboratories, Inc.
- FDA Inspection 1161511 - 2022-01-25
- FDA Inspection 1027427 - 2017-09-25
- FDA Inspection 823593 - 2013-03-22
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