# FDA 483 - Lornamead Inc. - January 21, 2026

Source: https://www.keypedia.com/records/483/lornamead-inc/4e84766a-900f-41f8-9a4c-45d86bf8093d

> FDA 483 for Lornamead Inc. on January 21, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lornamead Inc.
- Inspection Date: 2026-01-21
- Product Type: drugs
- Office Name: New York District Office
- Summary: LPNA Group Inc. DBA Lornamead Products was inspected and cited for significant deficiencies across its quality system. Observations included failures to properly record and justify deviations in laboratory testing, inadequate annual product review procedures, and deficient complaint handling processes. These issues indicate a lack of robust quality control and oversight in drug product manufacturing and release.

## Related Documents

- [483 - 2023-04-11](https://www.keypedia.com/records/483/lornamead-inc/666c43d8-a9c9-4ade-81ed-5d1800823a16)

## Related Officers

- [Lauren H. Augustyniak](https://www.keypedia.com/people/lauren-h-augustyniak/bde81fac-921f-494b-969b-38770fceda7e)

Company: https://www.keypedia.com/companies/lornamead-inc/708fee04-0f0a-4b8b-a6e6-ad520ec31a7d

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d