# FDA 483 - Delsam Pharma LLC - March 24, 2023

Source: https://www.keypedia.com/records/483/delsam-pharma-llc/26674d69-b27f-439f-91a0-cb44c84d91b8

> FDA 483 for Delsam Pharma LLC on March 24, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Delsam Pharma LLC
- Inspection Date: 2023-03-24
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Delsam Pharma LLC, an own-label distributor in Bronx, NY, was inspected and cited for significant deficiencies across its quality system. Observations include the absence of a quality control unit, improper storage conditions for sterile drug products, lack of complaint handling procedures, inadequate distribution records for recalls, and failure to conduct annual product reviews. These issues indicate a severe lack of fundamental controls for ensuring drug product quality and safety.

## Related Documents

- [WARNING_LETTER - 2023-03-24](https://www.keypedia.com/records/warning_letter/delsam-pharma-llc/02c02fdf-618c-40c4-81bb-a9ba4a3024b7)

## Related Officers

- [Mindy M. Chou](https://www.keypedia.com/people/mindy-m-chou/3d0e74bf-ad6b-48b5-8b72-cbb29e9c9ce5)

Company: https://www.keypedia.com/companies/delsam-pharma-llc/e139a8be-aefd-42f8-bd19-6804938def05

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961