# FDA 483 - Fenwal International, Inc. - September 26, 2019

Source: https://www.globalkeysolutions.net/records/483/fenwal-international-inc/7acd283f-7008-4143-a60d-8b3dc603bd5c

> FDA 483 for Fenwal International, Inc. on September 26, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fenwal International, Inc.
- Inspection Date: 2019-09-26
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: Fenwal International, Inc. in Maricao, PR, was inspected and received a Form 483 with six observations related to significant quality system deficiencies. The inspection revealed issues with laboratory data integrity, inadequate microbiological testing of components, and a lack of proper procedures to prevent contamination of sterile drug products. Additionally, the firm failed to maintain appropriate equipment design, follow complaint investigation procedures, and correctly identify in-process materials.

## Related Documents

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

- [Regulatory Project Manager](https://www.globalkeysolutions.net/people/nimmy-mathews/9eac44d1-5e4c-493a-89c5-c7414a5a4037)
- [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