# FDA 483 - SOCIETAL CDMO SAN DIEGO, LLC - January 25, 2023

Source: https://www.keypedia.com/records/483/societal-cdmo-san-diego-llc/1b68533f-12ee-4d1f-91d9-2fc9616ffe09

> FDA 483 for SOCIETAL CDMO SAN DIEGO, LLC on January 25, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SOCIETAL CDMO SAN DIEGO, LLC
- Inspection Date: 2023-01-25
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: SOCIETAL CDMO SAN DIEGO, LLC, a Contract Development and Manufacturing Organization, received three observations during an FDA inspection. The firm failed to thoroughly review unexplained discrepancies for distributed drug product batches and did not fully adhere to quality control unit procedures, including timely CAPA reviews and complete sample tracking. Additionally, the manufacturing facility's construction was deemed unsuitable due to a ceiling hole and unaddressed environmental excursions in a critical production room.

## Related Documents

- [EIR - 2021-04-07](https://www.keypedia.com/records/eir/societal-cdmo-san-diego-llc/c95db1b9-85ca-414f-9597-68f318fa29ab)
- [483 - 2021-04-07](https://www.keypedia.com/records/483/societal-cdmo-san-diego-llc/911b600e-f4f9-40ad-92f1-ab7dc46a8084)

## Related Officers

- [Rachel C. Stanton](https://www.keypedia.com/people/rachel-c-stanton/36495725-366c-4138-a4d8-df3ce38fa9cd)
- [https://www.fda.gov/media/120628/download](https://www.keypedia.com/people/santiago-gallardo-johnson/f5086b0c-c8fc-44dd-8d12-6506b9dd313f)

Company: https://www.keypedia.com/companies/societal-cdmo-san-diego-llc/62dca7b3-eae0-4594-9138-e540f9e03d62

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6