# FDA 483 - Recipharm Monts - June 09, 2015

Source: https://www.globalkeysolutions.net/records/483/recipharm-monts/a969c606-5a32-4b6e-80fc-b3174a273cf5

> FDA 483 for Recipharm Monts on June 09, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Recipharm Monts
- Inspection Date: 2015-06-09
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Recipharm Monts in Monts, France, revealed significant deficiencies in manufacturing practices. Observations included failures in preventing contamination during component handling and drug product filling, inadequate environmental controls for microorganisms, and insufficient laboratory testing for objectionable microorganisms in drug products. These issues indicate a lack of robust quality control in critical production areas.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/michael-e-maselli/84b393a9-864c-4150-a636-d4ee4a60c8af)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/nadeem-i-chaudhry/7d867939-2dc6-4503-b9b9-6f26b16c347e)

Company: https://www.globalkeysolutions.net/companies/recipharm-monts/b42ed4ff-aa0c-44b6-bf77-e8c82c7c5ea9

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321