FDA Inspection
Becton Dickinson Surgical Industries, LTDA.Becton Dickinson Surgical Industries, LTDA. – FDA Inspection, Feb 17, 2011
Record Details
This FDA Inspection record concerns Becton Dickinson Surgical Industries, LTDA., with an inspection on February 17, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 17, 2011
- Product Type
- Devices
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ID · d62125b8-b2a6-4bf5-af84-8ffc69c92a69
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 715811
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Becton Dickinson Surgical Industries, LTDA.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 15, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 30, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Becton Dickinson Surgical Industries, LTDA.
- FDA Inspection 1196701 - 2022-12-15
- FDA Inspection 940705 - 2015-07-30
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