# FDA 483 - Southwest Bio-Labs, Inc. - March 19, 2020

Source: https://www.globalkeysolutions.net/records/483/southwest-bio-labs-inc/8a75e96a-dbfa-4f38-bce7-6071d17526cb

> FDA 483 for Southwest Bio-Labs, Inc. on March 19, 2020. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Southwest Bio-Labs, Inc.
- Inspection Date: 2020-03-19
- Product Type: other
- Office Name: Denver District Office
- Summary: An FDA inspection of Southwest Bio-Labs, Inc. in Las Cruces, NM, a GLP facility, revealed 15 observations indicating significant non-compliance with Good Laboratory Practices. Deficiencies included a lack of independence in the quality assurance unit, inadequate equipment maintenance and environmental controls, and failures in adhering to study protocols. The report highlights systemic issues in documentation, adverse event reporting, and the archiving of raw data and specimens.

## Related Officers

- [Joo Jin](https://www.globalkeysolutions.net/people/joo-jin/adea8308-9b2f-4411-8de3-8dc505dc513f)
- [Stefanie T Ceto](https://www.globalkeysolutions.net/people/stefanie-t-ceto/d605a8ee-815d-4043-88ad-c146a1d53244)
- [Hugh F Macclure](https://www.globalkeysolutions.net/people/hugh-f-macclure/4ccd9dce-9d84-4c66-8a50-ae43e7b8f855)
- [Theressa B. Smith](https://www.globalkeysolutions.net/people/theressa-b-smith/80f0c339-7eac-4c73-b9f6-ecb368738fe6)

Company: https://www.globalkeysolutions.net/companies/southwest-bio-labs-inc/7c37e32c-e16f-4682-976d-889bcc28cb52

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