# FDA 483 - Recipharm Monts - February 26, 2013

Source: https://www.globalkeysolutions.net/records/483/recipharm-monts/01138d7a-dab5-495d-a5da-6e0f03eb5d1e

> FDA 483 for Recipharm Monts on February 26, 2013. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Recipharm Monts
- Inspection Date: 2013-02-26
- Product Type: drugs
- Office Name: FDA District Office — Silver Springs, Maryland
- Summary: Recipharm Monts, a drug product manufacturer in Monts, France, was cited for significant deficiencies in equipment design, maintenance, and procedural adherence during an FDA inspection. Observations included malfunctioning visual inspection systems leading to miscounts, inadequate complaint handling procedures, and a deficient stability testing program. These issues indicate a lack of control over critical manufacturing and quality processes.

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## Related Officers

- [S. Lori. Brown](https://www.globalkeysolutions.net/people/s-lori-brown/4bc9d367-3842-404d-a787-b8ce01e20da4)

Company: https://www.globalkeysolutions.net/companies/recipharm-monts/e3b2f0c3-26eb-4020-8127-76127e9e18d6

Office: https://www.globalkeysolutions.net/offices/fda-district-office-silver-springs-maryland/079bb75c-3759-4baa-baed-4159edd64552