# FDA 483 - 3D Imaging Drug Design and Development - January 31, 2024

Source: https://www.globalkeysolutions.net/records/483/3d-imaging-drug-design-and-development/b21c2326-aca9-4c9b-861d-baa1a8c486b6

> FDA 483 for 3D Imaging Drug Design and Development on January 31, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: 3D Imaging Drug Design and Development
- Inspection Date: 2024-01-31
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of 3D Imaging Drug Design and Development, a PET Drug Producer in Little Rock, AR, revealed significant deficiencies in their written procedures. The firm lacked adequate procedures for the receipt, evaluation, and reporting of post-marketing adverse drug experiences, as well as for the correct retention timeframe of drug product complaint records. These issues indicate a failure to establish proper controls for drug safety reporting and complaint handling.

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## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/michelle-j-hines/c8087e41-6b8a-4b9a-92ad-bba500ce6fee)

Company: https://www.globalkeysolutions.net/companies/3d-imaging-drug-design-and-development/52a34c85-0fab-4e15-8980-ba031bb418ce

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