# FDA 483 - Perma Laboratories LLC - June 08, 2018

Source: https://www.keypedia.com/records/483/perma-laboratories-llc/c6b90e9d-1104-4b76-9354-78de0dd61a76

> FDA 483 for Perma Laboratories LLC on June 08, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Perma Laboratories LLC
- Inspection Date: 2018-06-08
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Perme Laboratories LLC, a re-packer/re-labeler in Hinckley, OH, received a Form FDA 483 with 10 observations. The inspection revealed widespread deficiencies in the firm's quality system, including a lack of established procedures for corrective and preventive actions, non-conforming product control, complaint handling, medical device reporting, supplier control, document control, equipment calibration, quality audits, and labeling activities. These issues indicate a fundamental failure to implement and maintain a compliant quality system for medical devices.

## Related Officers

- [Investigator ](https://www.keypedia.com/people/benjamin-j-dastoli/688c2ad7-f7ac-47eb-8ca2-4efcd221f636)

Company: https://www.keypedia.com/companies/perma-laboratories-llc/20bbf9c2-3934-4b05-9991-c249ca905afa

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