FDA Inspection
Pihsiang Machinery Mfg Co LtdPihsiang Machinery Mfg Co Ltd – FDA Inspection, May 7, 2015
Record Details
This FDA Inspection record concerns Pihsiang Machinery Mfg Co Ltd, with an inspection on May 7, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 7, 2015
- Product Type
- Devices
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ID · 522bfc15-607c-42f6-b59d-89e011c62ea1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 926770
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(b)Supplier notification of changes
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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