# FDA 483 - Micro-Macinazione SA - May 31, 2019

Source: https://www.keypedia.com/records/483/micro-macinazione-sa/5bfb561f-edc4-4073-9ed6-d48ddb422597

> FDA 483 for Micro-Macinazione SA on May 31, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Micro-Macinazione SA
- Inspection Date: 2019-05-31
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Micro-Macinazione SA, a drug manufacturer in Monteggio, Switzerland, was cited for two significant issues during an FDA inspection. The firm's investigations into drug substance quality complaints were found to be inadequate, failing to assess the full scope of affected products and processes. Additionally, non-dedicated production equipment was not maintained in a good state of repair, posing a risk of cross-contamination of active pharmaceutical ingredients.

## Related Officers

- [Investigator](https://www.keypedia.com/people/edmund-f-mrak/a43cf86a-c020-4948-bff6-358b2453908a)

Company: https://www.keypedia.com/companies/micro-macinazione-sa/6f144812-4586-4004-8345-e0250ba95667

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd