# FDA 483 - Fenwal International, Inc. - September 18, 2024

Source: https://www.globalkeysolutions.net/records/483/fenwal-international-inc/9da39e05-129f-4655-9b84-85216d00b812

> FDA 483 for Fenwal International, Inc. on September 18, 2024. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Fenwal International, Inc.
- Inspection Date: 2024-09-18
- Product Type: biologics
- Office Name: San Juan District Office
- Summary: Fenwal International, Inc. in Maricao, PR, was inspected and received a Form 483 with seven observations. The inspection revealed significant issues including inadequately designed and maintained equipment, biological growth in critical environments, facility disrepair, and deficiencies in laboratory controls and environmental monitoring. Additionally, the firm failed to maintain adequate annual product reviews and handwashing facilities.

## Related Documents

- [483 - 2017-08-22](https://www.globalkeysolutions.net/records/483/fenwal-international-inc/3e3812a6-5c8d-4014-984d-a5f9a437dccf)
- [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)

## Related Officers

- [Lisoida Perez](https://www.globalkeysolutions.net/people/lisoida-perez/09ee31da-71b9-4846-b450-313737bf3332)
- [Kody T Aikman](https://www.globalkeysolutions.net/people/kody-t-aikman/f8927a91-abf2-43d1-8bb0-a2c4b1ad405f)
- [FDA_PERSONNEL](https://www.globalkeysolutions.net/people/lizaida-perez/686fbdca-bfd7-4a73-990a-d8a97e6b88b7)
- [Cody D. Rickman](https://www.globalkeysolutions.net/people/cody-d-rickman/54deec25-dc65-4402-991a-ad5589bad78b)
- [Scott T. Ballard](https://www.globalkeysolutions.net/people/scott-t-ballard/09b2ae9a-3b30-45bd-bac1-437365e938da)

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

Office: https://www.globalkeysolutions.net/offices/san-juan-district-office/27661cbf-5ba6-4c1b-9b39-4d6df63ca0e8