FDA Inspection
Lcr-hallcrest, Llc.Lcr-hallcrest, Llc. – FDA Inspection, Feb 26, 2010
Record Details
This FDA Inspection record concerns Lcr-hallcrest, Llc., with an inspection on February 26, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Lcr-hallcrest, Llc.
- Inspection Date
- February 26, 2010
- Product Type
- Devices
View Company Profile
ID · beabc8d9-5b2a-4341-99b2-eee4c16b7243
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 649662
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.198(e)(6)Results of investigation
- 21 CFR 820.90(a)Nonconforming product evaluation/investigation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Lcr-hallcrest, Llc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 27, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 12, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Lcr-hallcrest, Llc.
- FDA Inspection 1001750 - 2017-01-27
- FDA Inspection 883371 - 2014-06-12
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