FDA Inspection
ASP Plastics Pty Ltd.ASP Plastics Pty Ltd. – FDA Inspection, Feb 14, 2019
Record Details
This FDA Inspection record concerns ASP Plastics Pty Ltd., with an inspection on February 14, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- ASP Plastics Pty Ltd.
- Inspection Date
- February 14, 2019
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · cb05ee4b-7274-471a-a9b5-d3ecdbe9a37b
Inspection Facts
- Inspection number
- 1081212
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
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