# FDA 483 - Flamma USA LLC - June 20, 2025

Source: https://www.keypedia.com/records/483/flamma-usa-llc/975bec0e-a438-4620-b66f-16ac00d402bd

> FDA 483 for Flamma USA LLC on June 20, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Flamma USA LLC
- Inspection Date: 2025-06-20
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Flamma USA LLC, an API manufacturer in Malvern, PA, revealed significant deficiencies in quality control and manufacturing processes. Observations included a lack of written procedures for equipment cleanliness, inadequate laboratory testing facilities, and failure to implement formal change control for production changes. These issues indicate a need for improved adherence to good manufacturing practices.

## Related Documents

- [483 - 2025-06-20](https://www.keypedia.com/records/483/flamma-usa-llc/168c8e2a-71cd-4876-86f8-3da155e095fe)
- [483 - 2025-10-24](https://www.keypedia.com/records/483/flamma-usa-llc/901fa27e-b86a-42e6-8585-13e416688cd4)

## Related Officers

- [Karthik M. Krishnan](https://www.keypedia.com/people/karthik-m-krishnan/5ded6b7c-ef26-4a5f-b823-4eb017617d7c)
- [GDUFA Pharmaceutical Investigator](https://www.keypedia.com/people/kevin-p-regan/b870e1f2-017c-44ab-bc99-1ca99b474a04)

Company: https://www.keypedia.com/companies/flamma-usa-llc/e8b09d1a-f37b-4e4b-bff0-dc0533ac62f3

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8