FDA Inspection
LS Investment Group II LLCLS Investment Group II LLC – FDA Inspection, Oct 30, 2024
Record Details
This FDA Inspection record concerns LS Investment Group II LLC, with an inspection on October 30, 2024, issued by the Cincinnati District Office, covering medical devices & rad health.
- Company
- LS Investment Group II LLC
- Inspection Date
- October 30, 2024
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · ac1218a2-7f4c-43b9-963c-9a98b204f21e
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1252912
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of LS Investment Group II LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 5, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 12, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for LS Investment Group II LLC
- FDA Inspection 958102 - 2016-02-05
- FDA Inspection 858270 - 2013-12-12
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