# FDA 483 - Sparhawk Laboratories Inc - March 23, 2021

Source: https://www.keypedia.com/records/483/sparhawk-laboratories-inc/fbae89d7-7f56-411d-8ad5-30db5056a74a

> FDA 483 for Sparhawk Laboratories Inc on March 23, 2021. Product: veterinary. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sparhawk Laboratories Inc
- Inspection Date: 2021-03-23
- 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, received a Form 483 with three observations during an FDA inspection. The firm was cited for inadequate computer controls and data integrity issues, including a repeat observation regarding HPLC data and unprotected spreadsheet formulas. Additionally, the inspection revealed deficiencies in aseptic process validation and a lack of established procedures for preventing microbiological contamination, specifically concerning employee qualification for aseptic operations.

## Related Documents

- [483 - 2020-02-28](https://www.keypedia.com/records/483/sparhawk-laboratories-inc/a5e2a46f-c3b0-4454-9fe9-26012f84cd29)
- [483 - 2025-05-09](https://www.keypedia.com/records/483/sparhawk-laboratories-inc/18dcdbda-bfed-4f13-ba34-a26a0c5c8252)

## Related Officers

- [Wayne D. Mcgrath](https://www.keypedia.com/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)
- [Supervisory Consumer Safety Officer](https://www.keypedia.com/people/carl-a-huffman/4fa9a65e-2aa5-417c-8369-61edab77c57f)
- [Torrey M. Ward](https://www.keypedia.com/people/torrey-m-ward/e3021951-811e-45a0-a029-69c7cc862fcf)

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