# FDA 483 - Distron Corporation - March 20, 2024

Source: https://www.keypedia.com/records/483/distron-corporation/473d95c0-9ce0-4499-85bf-da9dbea5db42

> FDA 483 for Distron Corporation on March 20, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Distron Corporation
- Inspection Date: 2024-03-20
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Distron Corporation, a medical device manufacturer in Attleboro Falls, MA, identified two significant observations. The firm failed to adequately establish procedures for controlling storage areas and stock rooms, specifically lacking identification for quarantine and release areas. Additionally, acceptance activities were not adequately documented, with a tested and approved item missing proper records and management approval.

## Related Officers

- [investigator](https://www.keypedia.com/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

Company: https://www.keypedia.com/companies/distron-corporation/d8c4d6b5-a633-4c6e-99db-4b4cbd090be9

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