# SOCIETAL CDMO SAN DIEGO, LLC – FDA 483, Aug 28, 2026

Source: https://www.keypedia.com/records/483/societal-cdmo-san-diego-llc/ca3b05dc-210d-4e34-bc47-67778dc73353

> FDA 483 for SOCIETAL CDMO SAN DIEGO, LLC on August 28, 2026. 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: 2026-08-28
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: An FDA inspection of Societal CDMO San Diego, LLC, a drug manufacturer, revealed significant deficiencies in equipment cleaning validation, water system maintenance, and quality control processes. The firm failed to validate cleaning procedures, maintain its USP Purified Water System free of microbial contamination, and adequately investigate deviations and implement corrective actions in a timely manner. These issues indicate a moderate level of severity regarding GMP compliance.

## Related Documents

- [483 - 2023-01-25](https://www.keypedia.com/records/483/societal-cdmo-san-diego-llc/1b68533f-12ee-4d1f-91d9-2fc9616ffe09) — date: January 25, 2023
- [EIR - 2021-04-07](https://www.keypedia.com/records/eir/societal-cdmo-san-diego-llc/c95db1b9-85ca-414f-9597-68f318fa29ab) — date: April 7, 2021
- [483 - 2021-04-07](https://www.keypedia.com/records/483/societal-cdmo-san-diego-llc/911b600e-f4f9-40ad-92f1-ab7dc46a8084) — date: April 7, 2021

## Related Officers

- [Investigator](https://www.keypedia.com/people/desiree-d-clark/54497a7a-2f7c-47b6-8251-6acd2a9e0db5)
- [Regulatory Affairs Specialist](https://www.keypedia.com/people/andrew-le/573464c0-de29-4f64-ab33-62543b7fe719)
- [Consumer Safety Officer](https://www.keypedia.com/people/sangeeta-m-khurana/bed4533f-a9aa-47c5-9e0b-f20ad36461aa)
- [issuing_officer](https://www.keypedia.com/people/ngozi-g-offor/d9d0aa28-6bd1-4427-a712-8716c96b1f3d)
- [Devisree P. Mattigiri](https://www.keypedia.com/people/devisree-p-mattigiri/ecaf86a3-b2b0-4b07-907f-92632c3bbba9)

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

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b