FDA Inspection
Lusys Laboratories, Inc.Lusys Laboratories, Inc. – FDA Inspection, Dec 8, 2016
Record Details
This FDA Inspection record concerns Lusys Laboratories, Inc., with an inspection on December 8, 2016, issued by the Los Angeles District Office, covering medical devices & rad health.
- Company
- Lusys Laboratories, Inc.
- Inspection Date
- December 8, 2016
- Product Type
- Medical Devices & Rad Health
- People
- Shaquenta Y. Perkins (Issuing Officer)
- Theresa Kirkham
View Company Profile
ID · ca2db315-1c19-45e2-8bb1-3705f445a486
Inspection Facts
- Inspection number
- 994366
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
14- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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Other FDA inspections of Lusys Laboratories, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 24, 2021 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 7, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 21, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 19, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 21, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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