# FDA 483 - Select Corporation - September 14, 2023

Source: https://www.globalkeysolutions.net/records/483/select-corporation/ba0a9dd5-26ba-4eec-a397-5923b4e98b13

> FDA 483 for Select Corporation on September 14, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Select Corporation
- Inspection Date: 2023-09-14
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Select Corporation, a human drug repacker in Carrollton, TX, received a Form 483 for significant deficiencies observed during an FDA inspection. The firm lacked adequate written procedures for the receipt and inspection of incoming drug product shipments, leading to damaged products not being properly examined or quarantined. Additionally, the company's annual product review procedures were found to be deficient, failing to include reviews of deviations and investigations, and there was a systemic failure to record investigations into unexplained discrepancies.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/timothy-h-vo/08da7ca5-7f58-42bf-8046-e3a1bf879b48)

Company: https://www.globalkeysolutions.net/companies/select-corporation/2ae42b9d-c8f4-40cc-a48a-c2097e437153

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab