# FDA 483 - RK Pharma Inc. - August 12, 2022

Source: https://www.globalkeysolutions.net/records/483/rk-pharma-inc/5e26c4c2-1c01-4674-bfd8-3146fd524e34

> FDA 483 for RK Pharma Inc. on August 12, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RK Pharma Inc.
- Inspection Date: 2022-08-12
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: RK Pharma Inc. in Pearl River, NY, a sterile drug manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included a lack of quality control unit authority over production records and investigations, inadequately qualified manufacturing and testing equipment, and insufficient cleaning and maintenance procedures. Additionally, the firm failed to follow written production and process control procedures, indicating systemic issues in their quality management system.

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## Related Officers

- [Drug Investigator](https://www.globalkeysolutions.net/people/samir-c-gala/904c34ee-013d-4663-a87a-9cbdbcf2b40e)
- [Sam J Zamil](https://www.globalkeysolutions.net/people/sam-j-zamil/8199d01c-86c7-47a3-851b-3c5c40159e8c)
- [Mindy M. Chou](https://www.globalkeysolutions.net/people/mindy-m-chou/3d0e74bf-ad6b-48b5-8b72-cbb29e9c9ce5)

Company: https://www.globalkeysolutions.net/companies/rk-pharma-inc/04d6c855-6dac-45ed-8597-0541bddd3bce

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