# FDA 483 - Boston Scientific de Costa Rica SRL - June 02, 2022

Source: https://www.keypedia.com/records/483/boston-scientific-de-costa-rica-srl/54ef139b-1bbd-4734-a9aa-9bb1042f0f9c

> FDA 483 for Boston Scientific de Costa Rica SRL on June 02, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Boston Scientific de Costa Rica SRL
- Inspection Date: 2022-06-02
- Product Type: other
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Boston Scientific De Costa Rica, S.R.L. in El Coyol, Alajuela, Costa Rica, identified deficiencies in production and process control. The firm was cited for using numerous uncalibrated air pressure gauges in manufacturing and for not having specified regulator settings for these critical pieces of equipment. These conditions indicate a lack of adequate control over manufacturing processes for their medical devices.

## Related Officers

- [Sean T. Creighton](https://www.keypedia.com/people/sean-t-creighton/80ffecab-0a2d-4727-a11f-407b697f4503)

Company: https://www.keypedia.com/companies/boston-scientific-de-costa-rica-srl/096f57e4-8f37-4958-bacd-fb7d52e9fd4e

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd