# FDA 483 - Fenwal International, Inc. - August 22, 2017

Source: https://www.globalkeysolutions.net/records/483/fenwal-international-inc/3e3812a6-5c8d-4014-984d-a5f9a437dccf

> FDA 483 for Fenwal International, Inc. on August 22, 2017. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Fenwal International, Inc.
- Inspection Date: 2017-08-22
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: Fenwal International, Inc. in Maricao, PR, a sterile drug manufacturer, was cited for significant quality control deficiencies during an FDA inspection. The firm lacked adequate production and process controls, failed to thoroughly investigate discrepancies, and did not submit Field Alert Reports in a timely manner. Additionally, the facility experienced persistent pest infestations in critical manufacturing areas, indicating a severe lack of environmental control.

## Related Documents

- [483 - 2019-09-26](https://www.globalkeysolutions.net/records/483/fenwal-international-inc/7acd283f-7008-4143-a60d-8b3dc603bd5c)
- [483 - 2021-09-24](https://www.globalkeysolutions.net/records/483/fenwal-international-inc/dc43171b-5518-42d2-aa60-13313e5f7cd3)
- [483 - 2022-09-24](https://www.globalkeysolutions.net/records/483/fenwal-international-inc/2a02e7a0-6e2c-4030-aebb-9665cec946e0)
- [483 - 2024-09-18](https://www.globalkeysolutions.net/records/483/fenwal-international-inc/9da39e05-129f-4655-9b84-85216d00b812)

## Related Officers

- [Laurimer Kuilan-Torres](https://www.globalkeysolutions.net/people/laurimer-kuilan-torres/a7f49e33-9d35-4dfe-8bcc-d369d3834ef4)

Company: https://www.globalkeysolutions.net/companies/fenwal-international-inc/f7736da8-9a5b-421a-8f73-803b3504d456

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6