FDA Inspection
American Industrial Plastics, LLCAmerican Industrial Plastics, LLC – FDA Inspection, Jan 9, 2014
Record Details
This FDA Inspection record concerns American Industrial Plastics, LLC, with an inspection on January 9, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 9, 2014
- Product Type
- Devices
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ID · 8af94be4-60ef-4225-a4f7-248b5e338600
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 862413
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 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 American Industrial Plastics, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 16, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 7, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 18, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for American Industrial Plastics, LLC
- FDA Inspection 1223919 - 2023-11-16
- FDA Inspection 1101128 - 2019-08-07
- FDA Inspection 966848 - 2016-02-18
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