# FDA 483 - STERITECH, INC. - February 10, 2021

Source: https://www.globalkeysolutions.net/records/483/steritech-inc/ac6cf11e-bc92-471e-a3a5-ee3b76bf4d35

> FDA 483 for STERITECH, INC. on February 10, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: STERITECH, INC.
- Inspection Date: 2021-02-10
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: STERITECH, INC., a contract sterilization facility in Salinas, PR, was inspected by the FDA from February 3-10, 2021. The inspection revealed significant deficiencies in the firm's corrective and preventive action (CAPA) system, including a lack of established procedures and inadequate documentation of CAPA activities and effectiveness checks. Additionally, production processes were not consistently monitored to ensure devices conformed to specifications, with temperature deviations noted during batch record reviews.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/maricelys-mercado/de7e9ebc-8421-4fab-942e-6674fbdb4b1c)

Company: https://www.globalkeysolutions.net/companies/steritech-inc/d82fe0a3-7c69-46ed-82ff-4a3beef4eab9

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6