# FDA 483 - Hard Manufacturing Co., Inc. - March 06, 2025

Source: https://www.globalkeysolutions.net/records/483/hard-manufacturing-co-inc/89119466-b6d0-4d84-b808-b1a1e17a935b

> FDA 483 for Hard Manufacturing Co., Inc. on March 06, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hard Manufacturing Co., Inc.
- Inspection Date: 2025-03-06
- Product Type: device
- Office Name: New York District Office
- Summary: Hard Manufacturing Co., Inc. in Buffalo, NY, a medical device manufacturer, received a Form 483 with five observations. The inspection revealed significant deficiencies in process validation for welding and lathing, lack of documented in-process inspections, and inadequate corrective and preventive action procedures. Additionally, process control procedures for welding and software validation for production equipment were not established or adequately performed.

## Related Documents

- [483 - 2022-02-24](https://www.globalkeysolutions.net/records/483/hard-manufacturing-co-inc/4e69d569-cf64-445c-95e6-5fba2920d9be)

## Related Officers

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

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

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