# FDA 483 - Woodbine Products Company - September 01, 2022

Source: https://www.keypedia.com/records/483/woodbine-products-company/57ad6207-e0e2-4dc8-be24-daffd84d195f

> FDA 483 for Woodbine Products Company on September 01, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Woodbine Products Company
- Inspection Date: 2022-09-01
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: Woodbine Products Co Inc, an OTC drug manufacturer in Medina, OH, was cited for significant deficiencies in its quality control unit, including failure to test finished products and a lack of written procedures for critical operations. The inspection revealed insanitary conditions, inadequate raw material identity testing, and a complete absence of stability studies to support product expiration dates. These issues indicate a severe lack of control over drug product quality and manufacturing processes.

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Company: https://www.keypedia.com/companies/woodbine-products-company/b7fae119-8c1a-44b5-b3ce-11c0750b7689

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22