# FDA 483 - Moehs Catalana SL - May 18, 2018

Source: https://www.keypedia.com/records/483/moehs-catalana-sl/0d4b0fb2-cbfe-4df0-8756-3cc16d99cc37

> FDA 483 for Moehs Catalana SL on May 18, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Moehs Catalana SL
- Inspection Date: 2018-05-18
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Moehs Catalana S.L. in Rubi, Barcelona, revealed deficiencies in their quality control unit. The firm failed to properly calibrate HPLC analytical equipment to cover all testing wavelengths and lacked a formal risk assessment for swab sampling locations during cleaning validation. These issues indicate a failure to fully adhere to established responsibilities and procedures within the quality control unit.

## Related Officers

- [Consumer Safety Officer ](https://www.keypedia.com/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)

Company: https://www.keypedia.com/companies/moehs-catalana-sl/b2594fc0-fe99-4d1d-9b2d-4d71a3fea431

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