FDA Inspection
Bloomex International, Inc.Bloomex International, Inc. – FDA Inspection, May 1, 2009
Record Details
This FDA Inspection record concerns Bloomex International, Inc., with an inspection on May 1, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Bloomex International, Inc.
- Inspection Date
- May 1, 2009
- Product Type
- Devices
View Company Profile
ID · fa7e51ca-ce12-4a5f-909e-b6168528fd32
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 584472
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.198(a)General
- 21 CFR 820.20(b)(3)Management representative
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.100(b)Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Bloomex International, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 2, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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