# FDA 483 - PMC Isochem - February 17, 2017

Source: https://www.keypedia.com/records/483/pmc-isochem/61980006-9b2e-46dd-89d2-571982ab76d3

> FDA 483 for PMC Isochem on February 17, 2017. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: PMC Isochem
- Inspection Date: 2017-02-17
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: Isochem, an API manufacturer in Gennevilliers, France, received a Form 483 with seven observations during an FDA inspection from February 13-17, 2017. Significant issues included widespread data integrity failures, inadequate water system management, poor facility and equipment maintenance, and a deficient quality unit that failed to properly investigate complaints and out-of-specification results. This inspection highlighted critical deficiencies in the firm's quality systems and manufacturing controls.

## Related Officers

- [Consumer Safety Officer at Commissioned Corps of the U.S. Public Health Service](https://www.keypedia.com/people/latorie-s-jones/086d0897-7d63-4fa8-bdce-f1d17885abd7)

Company: https://www.keypedia.com/companies/pmc-isochem/3c9dd0f7-a1ab-41d2-8df5-14d947e81096

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4