# FDA 483 - NWL Netherlands Services B.V. - October 18, 2024

Source: https://www.keypedia.com/records/483/nwl-netherlands-services-bv/24d102b1-6384-4174-8707-773b565d7e18

> FDA 483 for NWL Netherlands Services B.V. on October 18, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NWL Netherlands Services B.V.
- Inspection Date: 2024-10-18
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: NWL Netherlands Services B.V., a drug manufacturer in Hillegom, was cited for significant deficiencies across its quality control unit, computer system controls, and laboratory operations. The inspection revealed failures in record-keeping, change control, stability studies, OOS investigations, data integrity, component identity testing, and water system monitoring. These issues indicate a systemic lack of adherence to good manufacturing practices, posing risks to drug product quality and purity.

## Related Documents

- [WARNING_LETTER - 2024-10-18](https://www.keypedia.com/records/warning_letter/nwl-netherlands-services-bv/6de8c943-773a-49a9-82ac-a4e0b831d4a9)

## Related Officers

- [Wayne D. Mcgrath](https://www.keypedia.com/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)

Company: https://www.keypedia.com/companies/nwl-netherlands-services-bv/b48400c5-c5c3-473b-86ca-24699f824d1c

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8