# FDA 483 - Steritec Products Mfg. Co., Inc. - December 01, 2022

Source: https://www.globalkeysolutions.net/records/483/steritec-products-mfg-co-inc/ff2a2d4f-d21b-4b4d-87fc-e82473215bca

> FDA 483 for Steritec Products Mfg. Co., Inc. on December 01, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Steritec Products Mfg. Co., Inc.
- Inspection Date: 2022-12-01
- Product Type: device
- Office Name: Denver District Office
- Summary: Steritec Products Mfc. Co., Inc. in Englewood, CO, a medical device manufacturer, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included inadequate design history files for Class II Migrating Indicator Strips, insufficient procedures for acceptance activities, and failures in controlling nonconforming products. These issues suggest a systemic lack of adherence to regulatory requirements for medical device manufacturing.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/christine-i-shaw/480cb61e-f173-432d-b84a-c8b492192302)

Company: https://www.globalkeysolutions.net/companies/steritec-products-mfg-co-inc/5c4ae5a4-e14a-4059-9ffd-85b7697464c8

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face