Drug establishmentActive, Registered FY2026FDA warning letter on file

NWL Netherlands Services B.V.

NWL Netherlands Services B.V. is an FDA-registered drug establishment (FEI 3003696942) located in . The facility is active, registered for FY2026. Its most recent FDA inspection on record (2024-10-18) was classified OAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Apr 1, 2025
CGMP/Finished Pharmaceuticals/Adulterated

A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.

Establishment record

FEI Number
3003696942
Address
Amperestraat 12, ,
Establishment type
Drug establishment
Products / operations
Analytical testing, Manufacturing, Relabeling, Repackaging
Registration status
Active, Registered FY2026

Verify this record on FDA.gov ›

Inspection history

Inspections on file
Oct 18, 2024 · Official Action Indicated (OAI)
Mar 7, 2014 · Official Action Indicated (OAI)
Form 483 observations
Oct 18, 2024, 6 observations: Computer control of master formula records; Scientifically sound laboratory controls; Procedures not in writing, fully followed

Questions

Is NWL Netherlands Services B.V. registered with the FDA?

Yes. NWL Netherlands Services B.V. is an FDA-registered drug establishment (FEI 3003696942) in . Its current registration status is Active, Registered FY2026.

Has NWL Netherlands Services B.V. received an FDA warning letter?

Yes. FDA issued a warning letter to NWL Netherlands Services B.V.; the most recent is dated Apr 1, 2025 (CGMP/Finished Pharmaceuticals/Adulterated).

What does NWL Netherlands Services B.V. do?

NWL Netherlands Services B.V.'s FDA-registered operations are: Analytical testing, Manufacturing, Relabeling, Repackaging.

Related facilities

Source: FDA public data · status as of 2026-06-06

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