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

Source: https://www.keypedia.com/records/483/nwl-netherlands-services-bv/3211b5a1-80cf-4f15-acc6-9369baa28ebd

> 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: Baltimore District Office
- Summary: An FDA inspection conducted from October 14-18, 2024, at NWL Netherlands Services B.V., a drug manufacturer in Hillegom, Zuid-Holland, identified multiple significant deviations from Good Manufacturing Practices. The primary issues observed centered on the company's quality control unit, computer system controls, and investigation procedures. Specifically, the firm lacked adequate written procedures for production and control records, with numerous instances of incomplete and unmanaged documentation. The quality unit did not consistently review or approve change controls, and stability study protocols were not followed. Investigations into deviations, non-conformances, and out-of-specification (OOS) results were found to be insufficient, lacking thorough root cause analysis and product impact assessments, and were not adequately reviewed by the quality unit. Furthermore, critical laboratory computer systems lacked appropriate controls, allowing unauthorized modification or deletion of analytical raw data, and shared user logins were prevalent. The identity of active pharmaceutical ingredients was not consistently verified for each incoming batch, and the purified water system exhibited defects due to untested points of use. Finally, the validation records for a drug product release testing method were incomplete. NWL Netherlands Services B.V. is required to address these deficiencies to ensure compliance with regulatory standards for drug manufacturing.

## Related Documents

- [483 - 2024-10-18](https://www.keypedia.com/records/483/nwl-netherlands-services-bv/24d102b1-6384-4174-8707-773b565d7e18)
- [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)
- [Drug Discovery and Biotech Executive](https://www.keypedia.com/people/lloyd-d-payne/8b98c38a-4fbe-465d-bb0a-689bcc6db702)

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

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa