# FDA 483 - Retro & R-Med Molding, LLC - July 22, 2021

Source: https://www.keypedia.com/records/483/retro-r-med-molding-llc/1f10fa9d-f0a9-4355-8b69-d2d410bb9311

> FDA 483 for Retro & R-Med Molding, LLC on July 22, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Retro & R-Med Molding, LLC
- Inspection Date: 2021-07-22
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Retro & R-Med Molding, LLC in Constantine, MI, a medical device manufacturer, received a Form 483 with nine observations following an FDA inspection. The inspection revealed a comprehensive lack of established written procedures across all critical quality system elements. This indicates significant deficiencies in the firm's quality management system, impacting areas from general quality system procedures to specific controls for manufacturing, equipment, and records.

## Related Officers

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

Company: https://www.keypedia.com/companies/retro-r-med-molding-llc/34fc4a22-71a7-4779-9dd1-d5b7a65ccab3

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