# FDA 483 - Moog Costa Rica, SRL - November 01, 2018

Source: https://www.globalkeysolutions.net/records/483/moog-costa-rica-srl/668897ca-ca0e-4f9e-b8db-104f987af26c

> FDA 483 for Moog Costa Rica, SRL on November 01, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Moog Costa Rica, SRL
- Inspection Date: 2018-11-01
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Moog Medical Devices Group, Srl in Alajuela, Costa Rica, a medical device manufacturer, received two observations during an FDA inspection. The firm's procedures for controlling environmental conditions in its cleanroom, including bioburden monitoring and employee gowning, were found to be inadequate. Additionally, the supplier evaluation system was deemed insufficient, as it allowed poorly performing suppliers to meet expectations.

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/benjamin-j-dastoli/688c2ad7-f7ac-47eb-8ca2-4efcd221f636)

Company: https://www.globalkeysolutions.net/companies/moog-costa-rica-srl/051536ac-f843-426f-b5a6-4805d1e99826

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