FDA Inspection
BLS Systems LtdBLS Systems Ltd – FDA Inspection, Aug 10, 2016
Record Details
This FDA Inspection record concerns BLS Systems Ltd, with an inspection on August 10, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- BLS Systems Ltd
- Inspection Date
- August 10, 2016
- Product Type
- Devices
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ID · 2d67129d-cb62-401c-81c7-5dac278605ec
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 983249
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of BLS Systems Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 18, 2019 | Not classified | Office of Inspections and Investigations |
Other documents for BLS Systems Ltd
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