# FDA 483 - The W.S. Badger Company, Inc. - September 14, 2021

Source: https://www.keypedia.com/records/483/the-ws-badger-company-inc/4ec86001-742d-4c3f-a3f4-ab3eb9b10483

> FDA 483 for The W.S. Badger Company, Inc. on September 14, 2021. 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: 2021-09-14
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: The W.S. Badger Company, Inc. in Gilsum, NH, was inspected regarding its manufacturing of OTC drug products. The inspection revealed significant deficiencies in process validation, quality control unit oversight, investigation of discrepancies, equipment cleaning validation, stability programs, and annual product reviews. Several observations were repeats from a previous inspection, indicating persistent issues with quality systems and compliance.

## Related Documents

- [WARNING_LETTER - 2021-09-14](https://www.keypedia.com/records/warning_letter/the-ws-badger-company-inc/3fa6a185-94b1-430a-a2cb-d10cfaf02d94)
- [483 - 2023-06-01](https://www.keypedia.com/records/483/the-ws-badger-company-inc/04d37824-e400-4e76-aac1-85d7f213c186)

## Related Officers

- [Pharmacy Intern/Certified Pharmacy Technician](https://www.keypedia.com/people/david-a-oluwo/209d60bd-27d8-487b-8249-1c6e44fcc317)
- [investigator](https://www.keypedia.com/people/lauren-n-barber/31610942-583f-4d3d-b870-077aead3e16f)

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