# FDA 483 - Standard Textile Co Inc - February 28, 2020

Source: https://www.globalkeysolutions.net/records/483/standard-textile-co-inc/1f9b6795-9b08-48b2-84ce-830b5f9947fd

> FDA 483 for Standard Textile Co Inc on February 28, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Standard Textile Co Inc
- Inspection Date: 2020-02-28
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Standard Textile Co Inc, a medical device specification developer in Cincinnati, OH, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, including validation of such actions and related software. Additionally, procedures for rework of nonconforming products were not defined, and critical quality system documents were not readily available at all necessary locations.

## Related Documents

- [WARNING_LETTER - 2013-02-08](https://www.globalkeysolutions.net/records/warning_letter/standard-textile-co-inc/a9214fc3-9ca0-4c5b-9103-347e3dfe04d7)

## Related Officers

- [Benjamin E. Bowen](https://www.globalkeysolutions.net/people/benjamin-e-bowen/7fdc5755-0d5d-45c9-93a0-3cb928156c1d)
- [Consumer Safety Officer, Medical Device Specialist](https://www.globalkeysolutions.net/people/teresa-kastner/32a8d75e-770d-48cc-80e0-2eb5ad57e560)

Company: https://www.globalkeysolutions.net/companies/standard-textile-co-inc/2d5f139d-52c5-4b8d-8ca7-7ba1c22bef27

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22