# FDA 483 - Woodbine Products Company - February 13, 2026

Source: https://www.keypedia.com/records/483/woodbine-products-company/d7f3fdff-8e64-4c56-ae6d-47de65c4c5fe

> FDA 483 for Woodbine Products Company on February 13, 2026. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Woodbine Products Company
- Inspection Date: 2026-02-13
- Product Type: drugs
- Office Name: FDA District Office — Cincinnati, Ohio
- Summary: Woodbine Products Company Inc. in Medina, OH, received a Form 483 with six observations following an FDA inspection from February 9-13, 2026. The inspection revealed significant deficiencies across multiple areas, including inadequate component identity testing, premature release of finished drug products, and a lack of essential written procedures for quality control and process validation. These findings indicate a systemic failure to ensure the quality, purity, and strength of their OTC drug products.

## Related Documents

- [483 - 2022-09-01](https://www.keypedia.com/records/483/woodbine-products-company/57ad6207-e0e2-4dc8-be24-daffd84d195f)
- [WARNING_LETTER - 2026-02-13](https://www.keypedia.com/records/warning_letter/woodbine-products-company/fb5e6617-379e-4ff7-b43f-325b2d8e24bf)

## Related Officers

- [Supreet K. Sran](https://www.keypedia.com/people/supreet-k-sran/1dab51f8-b483-4ccb-8b44-89fdc3b8100b)

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

Office: https://www.keypedia.com/offices/fda-district-office-cincinnati-ohio/b4972fd9-9db9-4cc6-9a4c-0146959c9d74