# FDA 483 - K. W. Griffen Company DBA Biomed Packaging Systems - May 16, 2025

Source: https://www.keypedia.com/records/483/k-w-griffen-company-dba-biomed-packaging-systems/5977ed6b-9563-41fe-a227-f51daac56f4a

> FDA 483 for K. W. Griffen Company DBA Biomed Packaging Systems on May 16, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: K. W. Griffen Company DBA Biomed Packaging Systems
- Inspection Date: 2025-05-16
- Product Type: drugs
- Office Name: New England District Office
- Summary: K.W. Griffen Company in Norwalk, CT, was inspected by the FDA, revealing six observations primarily concerning the manufacturing of their 4% Chlorhexidine Surgical Scrub Brush-Sponge and Nail Pick combination product. Deficiencies included a lack of process validation, inadequate equipment qualification documentation, and significant issues within the quality control unit regarding procedures for deviations, stability data review, and supplier qualification. Additionally, the firm failed to conduct cleaning validation studies, properly manage retain samples, and control access to labeling materials, indicating a broad lack of cGMP compliance.

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## Related Officers

- [Josh Renzo N. Ramilo](https://www.keypedia.com/people/josh-renzo-n-ramilo/5b0850ba-e22a-42fc-9310-2beeb921f8f6)

Company: https://www.keypedia.com/companies/k-w-griffen-company-dba-biomed-packaging-systems/4f4e6ca6-e91b-44e7-a5d1-52537169f3a4

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144