# STERITECH, INC. – FDA 483, Dec 8, 2023

Source: https://www.keypedia.com/records/483/steritech-inc/11011c25-27ee-464f-9007-b45064fd7c3e

> FDA 483 for STERITECH, INC. on December 08, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: STERITECH, INC.
- Inspection Date: 2023-12-08
- Product Type: device
- Office Name: Center for Devices and Radiological Health
- Summary: During an inspection, contract sterilizer STERITECH, INC. in Salinas, PR, received a Form FDA 483 with one observation. The firm was cited for failing to establish procedures for periodic equipment maintenance inspections. Additionally, the inspection found that the firm did not adhere to its own established preventive maintenance procedures for replacing specific components.

## Related Documents

- [483 - 2021-02-10](https://www.keypedia.com/records/483/steritech-inc/ac6cf11e-bc92-471e-a3a5-ee3b76bf4d35) — date: February 10, 2021
- [EIR - 2021-02-10](https://www.keypedia.com/records/eir/steritech-inc/613f5a74-efd7-434e-bcc8-3e47d157a83f) — date: February 10, 2021
- [EIR - 2019-02-19](https://www.keypedia.com/records/eir/steritech-inc/e878b14d-0b10-47f8-89ae-38743cd208a6) — date: February 19, 2019

## Related Officers

- [Nydia E. Colon](https://www.keypedia.com/people/nydia-e-colon/c5137ded-6ae7-4855-b5b3-113bd851e1c3)

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

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7