# FDA 483 - Nellcor Puritan Bennett Mexico, S.A. de C.V. - November 05, 2004

Source: https://www.keypedia.com/records/483/nellcor-puritan-bennett-mexico-sa-de-cv/58e1b09f-6a88-4ecc-bb60-ebeb6aae32b8

> FDA 483 for Nellcor Puritan Bennett Mexico, S.A. de C.V. on November 05, 2004. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nellcor Puritan Bennett Mexico, S.A. de C.V.
- Inspection Date: 2004-11-05
- Product Type: device
- Office Name: Center for Veterinary Medicine
- Summary: An FDA inspection of Nellcor Puritan Bennett Mexico, S.A. de C.V. in Tijuana B.C. revealed critical deficiencies in their medical device manufacturing processes. The firm failed to adequately monitor and control bioburden on CapnoProbe sensors during production. This lapse led to significant bacterial contamination, including Burkholderia cepacia and Stenotrophamonas maltaphilia, and was associated with possible consumer injuries.

## Related Officers

- [ Assistant Deputy Chief](https://www.keypedia.com/people/sergio-chavez/666c6fc6-b829-4865-b896-947ff3e114d5)

Company: https://www.keypedia.com/companies/nellcor-puritan-bennett-mexico-sa-de-cv/b1de454f-04ae-47ad-b7f4-2cdb96131c22

Office: https://www.keypedia.com/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4