FDA Inspection
Alliance Precision Plastics CorporationAlliance Precision Plastics Corporation – FDA Inspection, Mar 30, 2018
Record Details
This FDA Inspection record concerns Alliance Precision Plastics Corporation, with an inspection on March 30, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a3f3326f-3431-48de-87aa-c7124fe9a9ed
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1046543
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
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 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Alliance Precision Plastics Corporation
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 20, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 4, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Alliance Precision Plastics Corporation
- FDA Inspection 1226326 - 2023-12-20
- FDA Inspection 1143298 - 2021-06-04
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