# FDA 483 - Hobbs Medical, Inc. - August 27, 2021

Source: https://www.keypedia.com/records/483/hobbs-medical-inc/de4caff4-fe02-4862-94c1-6b2d6a5bd680

> FDA 483 for Hobbs Medical, Inc. on August 27, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hobbs Medical, Inc.
- Inspection Date: 2021-08-27
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Hobbs Medical, Inc. in Stafford Springs, CT, a medical device manufacturer, was cited for three observations during an FDA inspection. The firm failed to adequately maintain device history records and device master records. Additionally, production processes were not controlled to ensure devices conform to specifications, indicating deficiencies in their quality system.

## Related Officers

- [Katarzyna Plona](https://www.keypedia.com/people/katarzyna-plona/ea20d6c6-5d2d-41a0-a755-0647fb9f3250)
- [investigator](https://www.keypedia.com/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

Company: https://www.keypedia.com/companies/hobbs-medical-inc/9256d6ee-bdf4-4127-b992-eccce68ad1b1

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