FDA Inspection
Plas-Tech Engineering Inc.Plas-Tech Engineering Inc. – FDA Inspection, Jan 24, 2011
Record Details
This FDA Inspection record concerns Plas-Tech Engineering Inc., with an inspection on January 24, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Plas-Tech Engineering Inc.
- Inspection Date
- January 24, 2011
- Product Type
- Devices
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ID · c2916ba5-4624-4796-8eb2-69e400c5f6fb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 706737
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50(b)Approval, inadequate purchasing data
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Plas-Tech Engineering Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 5, 2025 | Not classified | Minneapolis District Office |
Other documents for Plas-Tech Engineering Inc.
- FDA Inspection 1263224 - 2025-03-05
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