# FDA 483 - Sparhawk Laboratories Inc - February 28, 2020

Source: https://www.keypedia.com/records/483/sparhawk-laboratories-inc/a5e2a46f-c3b0-4454-9fe9-26012f84cd29

> FDA 483 for Sparhawk Laboratories Inc on February 28, 2020. Product: veterinary. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sparhawk Laboratories Inc
- Inspection Date: 2020-02-28
- Product Type: veterinary
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Sparhawk Laboratories Inc., an animal drug manufacturer in Lenexa, KS, was cited for significant deficiencies across multiple areas during an FDA inspection. The observations highlight failures in complaint handling, data integrity for analytical testing, inadequate stability testing to support storage conditions, incomplete batch records, and a lack of robust written procedures for critical production and process controls, including those for preventing microbiological contamination in sterile products. These issues indicate a systemic lack of control over critical quality systems.

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## Related Officers

- [Laura S. Huffman](https://www.keypedia.com/people/laura-s-huffman/13973f9f-7c20-4a9a-bdbe-a973cfaacec6)
- [Ana F. Sandee](https://www.keypedia.com/people/ana-f-sandee/2f5c053f-73d2-43e3-85a3-7565d73a9d29)
- [Supervisory Consumer Safety Officer](https://www.keypedia.com/people/carl-a-huffman/4fa9a65e-2aa5-417c-8369-61edab77c57f)
- [James K. Rice](https://www.keypedia.com/people/james-k-rice/b8d40430-5ff3-478c-a141-e83eefaac022)

Company: https://www.keypedia.com/companies/sparhawk-laboratories-inc/0edcf26d-ffdf-460f-b9fd-264b336000d5

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8