# FDA 483 - Robin Industries Healthcare Division - September 26, 2023

Source: https://www.globalkeysolutions.net/records/483/robin-industries-healthcare-division/f4e371a7-52d5-4add-993d-a4dee416994a

> FDA 483 for Robin Industries Healthcare Division on September 26, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Robin Industries Healthcare Division
- Inspection Date: 2023-09-26
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Robin Industries Healthcare Division, a medical device manufacturer in Berlin, OH, was inspected and received a Form FDA 483 with three observations. The inspection revealed significant deficiencies in the firm's quality system, including inadequate corrective and preventive action procedures, undocumented equipment maintenance and cleaning activities, and a lack of control over critical documents. These issues indicate a systemic breakdown in maintaining a compliant quality management system.

## Related Officers

- [Medical Device Specialist](https://www.globalkeysolutions.net/people/rosanna-m-goodrich/44c5c743-f67b-41fe-9cd1-8b5913bf580e)

Company: https://www.globalkeysolutions.net/companies/robin-industries-healthcare-division/f1b2160d-cbca-4f9e-b303-362644b5297d

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22