FDA Inspection
Biometerplususa Inc.Biometerplususa Inc. – FDA Inspection, May 14, 2010
Record Details
This FDA Inspection record concerns Biometerplususa Inc., with an inspection on May 14, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Biometerplususa Inc.
- Inspection Date
- May 14, 2010
- Product Type
- Devices
View Company Profile
ID · a3152694-bc43-465e-ac6b-5ada40dc3e16
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 658684
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 820.198(a)General
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Biometerplususa Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 25, 2026 | VAI | San Francisco District Office | Compliance: Medical Devices |
| July 21, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 3, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 25, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Biometerplususa Inc.
- FDA Inspection 1309260 - 2026-03-25
- FDA Inspection 981334 - 2016-07-21
- FDA Inspection 722592 - 2011-05-03
- FDA Inspection 615040 - 2009-09-25
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