# FDA 483 - The W.S. Badger Company, Inc. - June 01, 2023

Source: https://www.keypedia.com/records/483/the-ws-badger-company-inc/04d37824-e400-4e76-aac1-85d7f213c186

> FDA 483 for The W.S. Badger Company, Inc. on June 01, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: The W.S. Badger Company, Inc.
- Inspection Date: 2023-06-01
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: The W.S. Badger Company, Inc. in Gilsum, NH, a drug manufacturer, was cited for numerous significant deficiencies during an FDA inspection. The observations highlight a systemic failure to thoroughly investigate discrepancies, establish adequate microbiological controls, maintain proper documentation, and validate critical laboratory methods and equipment. Many of these issues are repeat observations from previous inspections, indicating persistent non-compliance.

## Related Documents

- [483 - 2021-09-14](https://www.keypedia.com/records/483/the-ws-badger-company-inc/4ec86001-742d-4c3f-a3f4-ab3eb9b10483)
- [WARNING_LETTER - 2021-09-14](https://www.keypedia.com/records/warning_letter/the-ws-badger-company-inc/3fa6a185-94b1-430a-a2cb-d10cfaf02d94)

## Related Officers

- [M.S., Consumer Safety Officer at FDA](https://www.keypedia.com/people/daniel-l-zheng/5e3d993f-654e-4d40-a2c8-69c5e396499f)
- [Deputy Director](https://www.keypedia.com/people/lori-m-newman/a0e448e4-11ba-4095-b879-feabb8750b3f)

Company: https://www.keypedia.com/companies/the-ws-badger-company-inc/dd58643d-4e87-499b-b49a-1825666553fe

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94