FDA Inspection
BL Healthcare, IncorporatedBL Healthcare, Incorporated – FDA Inspection, Mar 30, 2015
Record Details
This FDA Inspection record concerns BL Healthcare, Incorporated, with an inspection on March 30, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- BL Healthcare, Incorporated
- Inspection Date
- March 30, 2015
- Product Type
- Devices
View Company Profile
ID · 9717d1c5-da74-49aa-ab77-4df5d4390e8d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 924456
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.80(d)(3)No release signature
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.25(b)Training records
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.184(e)ID label, labeling
- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of BL Healthcare, Incorporated
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 20, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 22, 2008 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for BL Healthcare, Incorporated
- FDA Inspection 772953 - 2012-03-20
- FDA Inspection 542890 - 2008-10-22
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