# FDA 483 - SV Labs Prescott Corporation - September 28, 2018

Source: https://www.keypedia.com/records/483/sv-labs-prescott-corporation/0bea7edd-a20f-49e1-8ff7-736bc60e6c9b

> FDA 483 for SV Labs Prescott Corporation on September 28, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SV Labs Prescott Corporation
- Inspection Date: 2018-09-28
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: Diversified Manufacturing Corporation in Prescott, WI, a manufacturer of human and animal drugs, was cited for numerous significant deficiencies during an FDA inspection. The observations highlight severe breakdowns in quality control, including failure to reject out-of-specification products and inadequate investigation procedures. Additionally, the firm exhibited critical issues in laboratory controls, equipment qualification, data integrity, and labeling management, indicating a pervasive lack of adherence to current good manufacturing practices.

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Company: https://www.keypedia.com/companies/sv-labs-prescott-corporation/3fa073ed-17f3-40c6-930b-6f5b2905ee5d

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d