# FDA 483 - Lornamead Inc. - April 11, 2023

Source: https://www.globalkeysolutions.net/records/483/lornamead-inc/666c43d8-a9c9-4ade-81ed-5d1800823a16

> FDA 483 for Lornamead Inc. on April 11, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lornamead Inc.
- Inspection Date: 2023-04-11
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Lornamead Inc., a drug manufacturer in Tonawanda, NY, was inspected and cited for significant deficiencies across multiple areas. These include failures in raw material identity testing, inadequate complaint handling for adverse events, insufficient investigations into out-of-specification results, lack of proper temperature control for storage, and non-adherence to procedures for managing rejected drug products. The observations indicate a need for comprehensive improvements in their quality control and manufacturing processes.

## Related Documents

- [483 - 2026-01-21](https://www.globalkeysolutions.net/records/483/lornamead-inc/4e84766a-900f-41f8-9a4c-45d86bf8093d)

## Related Officers

- [William Leonard](https://www.globalkeysolutions.net/people/william-leonard/1f11ece4-597c-4d3e-aac4-46f8ea404ec3)

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961