# FDA 483 - Gimopharm Sarl - July 30, 2019

Source: https://www.globalkeysolutions.net/records/483/gimopharm-sarl/ed827d83-9d60-4d7e-a84e-2596db5c701f

> FDA 483 for Gimopharm Sarl on July 30, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gimopharm Sarl
- Inspection Date: 2019-07-30
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: This FDA Form 483 report details significant deficiencies at Ginopharm Sarl, a contract testing laboratory in Longjumeau, France, following an inspection from July 29-30, 2019. The observations highlight inadequate laboratory controls, poor record-keeping, failures within the quality control unit, and insufficient employee training, with several issues being repeat observations from a 2014 inspection. These findings indicate a lack of adherence to current good manufacturing practice regulations.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/charles-l-zhou/b55d1247-06de-4c7e-80d8-5ed2f801d259)

Company: https://www.globalkeysolutions.net/companies/gimopharm-sarl/f906cf15-98a8-43ef-be75-e19ef28061f9

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1