# FDA 483 - AstraZeneca Pharmaceuticals LP - September 19, 2023

Source: https://www.globalkeysolutions.net/records/483/astrazeneca-pharmaceuticals-lp/588ae947-ca3a-4174-83f6-d54fc5ae8752

> FDA 483 for AstraZeneca Pharmaceuticals LP on September 19, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AstraZeneca Pharmaceuticals LP
- Inspection Date: 2023-09-19
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: AstraZeneca Pharmaceuticals LP in Mount Vernon, IN, was inspected by the FDA, resulting in two observations. The inspection revealed deficiencies in following written procedures for in-process controls, specifically regarding tablet weight assessment and handling out-of-specification results. Additionally, laboratory records were found to be deficient due to inadequate control and retention of analytical worksheets.

## Related Officers

- [Joseph A. Piechocki](https://www.globalkeysolutions.net/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)

Company: https://www.globalkeysolutions.net/companies/astrazeneca-pharmaceuticals-lp/80a406f0-7f62-4d81-841e-7f01c9950c06

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0