# FDA 483 - Maitland Engineering. Inc. - October 15, 2021

Source: https://www.globalkeysolutions.net/records/483/maitland-engineering-inc/a01d1977-3173-4b79-9a32-54f2ea70b298

> FDA 483 for Maitland Engineering. Inc. on October 15, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Maitland Engineering. Inc.
- Inspection Date: 2021-10-15
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Maitland Engineering, Inc. in South Bend, IN, a medical device manufacturer, was cited for inadequate corrective and preventive action (CAPA) procedures. The firm failed to properly classify and initiate CAPAs for recurring nonconforming products, specifically screws, despite multiple Nonconformance Reports (NCRs) identifying similar defects. This indicates a systemic issue in addressing product quality problems.

## Related Officers

- [ Investigator ](https://www.globalkeysolutions.net/people/suyang-qin/c32419c5-1b78-4014-9f94-cb7ab17dfe05)

Company: https://www.globalkeysolutions.net/companies/maitland-engineering-inc/03cb1b77-f1cf-4b3f-8333-0deaa1479247

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0