# Hard Manufacturing Co., Inc. – FDA 483, Apr 7, 2026

Source: https://www.keypedia.com/records/483/hard-manufacturing-co-inc/9a732a2d-8c1d-4273-83d1-0e8b689bd2c2

> FDA 483 for Hard Manufacturing Co., Inc. on April 07, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hard Manufacturing Co., Inc.
- Inspection Date: 2026-04-07
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Hard Manufacturing Co., Inc., a medical device manufacturer in Buffalo, NY, revealed two significant observations. The firm failed to adequately document procedures for design and development changes, specifically lacking verification or validation for material changes. Additionally, the company's risk management processes were not adequately documented, failing to clearly require risk assessments for patient harms or manufacturing processes.

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## Related Officers

- [Matthew D. Schnittker](https://www.keypedia.com/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

Company: https://www.keypedia.com/companies/hard-manufacturing-co-inc/d76bb2f8-d74d-46fd-a552-22631a4ba5d0

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