Mr. Jimmy Duivenvoorden
Site Manager
NWL Netherlands Services B.V.
Amperestraat 12 Hillegom
2181 HB Zuid-Holland
Netherlands
Jimmy.duivenvoorden@newellco.comFEI 3003696942Issued Apr 1, 2025Center for Drug Evaluation and Research (CDER)
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3003696942.
Violations4
Issue DateApr 1, 2025
Product TypeDrugs
StatusOpen
Letter Details
Firm
NWL Netherlands Services B.V.
Location
Mr. Jimmy Duivenvoorden
Site Manager
NWL Netherlands Services B.V.
Amperestraat 12 Hillegom
2181 HB Zuid-Holland
Netherlands
Jimmy.duivenvoorden@newellco.com
FEI Number
3003696942
Country
Netherlands
Issue Date
April 01, 2025
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
NWL Netherlands Services B.V., a drug manufacturing facility in the Netherlands, was cited for significant Current Good Manufacturing Practice (CGMP) violations that rendered their finished pharmaceutical products adulterated. The company failed to conduct adequate investigations into out-of-limit microbial contamination results in a critical manufacturing system, including seven contamination events in 2024 with results as high as 10,000 CFU/mL, and did not perform sufficient root cause analysis, corrective actions, or preventive actions (CAPAs) for batch discrepancies. The facility's inadequate investigation protocols were particularly concerning because the contaminated component from this system was used as a major component in their drug products.
NWL Netherlands Services B.V. FDA Warning Letter, April 1, 2025