# FDA 483 - R&D Engineering, Inc. of Earlham - December 15, 2022

Source: https://www.globalkeysolutions.net/records/483/rd-engineering-inc-of-earlham/a00e3c14-0a86-45f0-96bf-6ee9c7d2b29c

> FDA 483 for R&D Engineering, Inc. of Earlham on December 15, 2022. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: R&D Engineering, Inc. of Earlham
- Inspection Date: 2022-12-15
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: R&D Engineering, Inc. of Earlham, a manufacturer of Class 2 medical devices, was cited for two significant observations during an FDA inspection. The firm failed to establish written procedures for device history records, leading to incomplete documentation for its 800cc Suction Canisters. Additionally, obsolete work instructions were found in use at the point of operation, indicating deficiencies in their document control system.

## Related Documents

- [483 - 2025-04-23](https://www.globalkeysolutions.net/records/483/rd-engineering-inc-of-earlham/0fbe026c-0514-4430-a37c-7add948787a6)

## Related Officers

- [Clifford F. Long](https://www.globalkeysolutions.net/people/clifford-f-long/846e5a0c-cb7c-421c-86aa-be9fddfbaaba)

Company: https://www.globalkeysolutions.net/companies/rd-engineering-inc-of-earlham/2f399ceb-79e5-476a-9bed-93247ecfebcd

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8