# FDA 483 - Becton Dickinson & Company - March 17, 2020

Source: https://www.keypedia.com/records/483/becton-dickinson-company/c6a62f01-d862-44c6-856a-72cb5dbc1495

> FDA 483 for Becton Dickinson & Company on March 17, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Becton Dickinson & Company
- Inspection Date: 2020-03-17
- Product Type: device
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Becton Dickinson & Company in Franklin Lakes, NJ, from February 3 to March 17, 2020, revealed significant deficiencies in quality system procedures. The firm failed to adequately establish complaint handling procedures and submit Medical Device Reports (MDRs) within the required timeframe, both of which were repeat observations. Additionally, the inspection found that sampling methods for quality control were not adequately established or documented.

## Related Documents

- [483 - 2017-07-06](https://www.keypedia.com/records/483/becton-dickinson-company/c7108683-0e83-45b0-8c86-f909e1d5ed3b)
- [WARNING_LETTER - 2017-07-06](https://www.keypedia.com/records/warning_letter/becton-dickinson-company/613055a1-0377-4a19-9ec4-88a837aacfb2)

## Related Officers

- [Michelle L Johnson](https://www.keypedia.com/people/michelle-l-johnson/7a31a805-4066-41ec-9f65-f1f907695044)
- [Senior Advisor](https://www.keypedia.com/people/yung-w-chan/d36960ee-f319-4dfb-a2f4-701e30ea466a)
- [Melissa Zuppe](https://www.keypedia.com/people/melissa-zuppe/e34e3943-0e3c-4a24-983d-6ac8aa2cc906)

Company: https://www.keypedia.com/companies/becton-dickinson-company/7753d11c-756c-4643-bb9e-51b2e99a099d

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248