# FDA 483 - Tubilux Pharma Spa - December 02, 2019

Source: https://www.globalkeysolutions.net/records/483/tubilux-pharma-spa/6d9db35b-df99-4eae-9199-56bea218c80d

> FDA 483 for Tubilux Pharma Spa on December 02, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Tubilux Pharma Spa
- Inspection Date: 2019-12-02
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Tubilux Pharma Spa in Pomezia, Italy, received a Form 483 with four observations during an FDA inspection from December 2-10, 2019. The inspection revealed significant issues across quality systems, including inadequate review of biological indicator data for sterile products, deficient complaint investigations for packaging malfunctions, and failures within the quality control unit regarding viscosity test evaluations and supplier controls. These findings indicate a moderate level of concern regarding the firm's adherence to cGMPs for drug manufacturing.

## Related Documents

- [WARNING_LETTER - 2016-12-09](https://www.globalkeysolutions.net/records/warning_letter/tubilux-pharma-spa/c8ae5092-6c27-4868-85f5-19a87dfb6509)

## Related Officers

- [Melanie Walker](https://www.globalkeysolutions.net/people/melanie-walker/fd9d56d8-ff97-4d11-94de-89711d91e51e)
- [Dennis Castellops](https://www.globalkeysolutions.net/people/dennis-castellops/e3936f53-2a46-4b48-983f-79a78bba432a)

Company: https://www.globalkeysolutions.net/companies/tubilux-pharma-spa/83daee41-4a1b-4274-bb2a-3922dcf3e9a4

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