FDA Inspection
LSL Healthcare Inc.LSL Healthcare Inc. – FDA Inspection, Feb 24, 2012
Record Details
This FDA Inspection record concerns LSL Healthcare Inc., with an inspection on February 24, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- LSL Healthcare Inc.
- Inspection Date
- February 24, 2012
- Product Type
- Devices
View Company Profile
ID · b309ca95-b147-43d8-b86e-740fccee956a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 769870
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.90(a)Nonconforming product control
Full citation text and observation details available on the Dashboard.
Other FDA inspections of LSL Healthcare Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 25, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 21, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 30, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for LSL Healthcare Inc.
- FDA Inspection 991817 - 2016-10-25
- FDA Inspection 803838 - 2012-09-21
- FDA Inspection 582131 - 2009-04-30
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