# FDA 483 - Fenwal International, Inc. - September 24, 2022

Source: https://www.globalkeysolutions.net/records/483/fenwal-international-inc/2a02e7a0-6e2c-4030-aebb-9665cec946e0

> FDA 483 for Fenwal International, Inc. on September 24, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fenwal International, Inc.
- Inspection Date: 2022-09-24
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: Fenwal International, Inc. in Maricao, PR, was cited for significant deficiencies in its drug manufacturing operations, particularly concerning quality control, environmental monitoring, and aseptic processing. The inspection revealed failures in investigating out-of-specification results, maintaining clean and properly designed facilities and equipment, and establishing adequate procedures to prevent microbiological contamination. These issues indicate a high risk of product contamination and compromise of drug product quality.

## 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 - 2024-09-18](https://www.globalkeysolutions.net/records/483/fenwal-international-inc/9da39e05-129f-4655-9b84-85216d00b812)

## Related Officers

- [Scott T. Ballard](https://www.globalkeysolutions.net/people/scott-t-ballard/09b2ae9a-3b30-45bd-bac1-437365e938da)
- [Laura E. Garcia](https://www.globalkeysolutions.net/people/laura-e-garcia/ad7c9bee-bbff-494f-b9cf-35c3a04316c0)

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