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

The FDA inspected NWL Netherlands Services B.V. from October 14-18, 2024, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated per 21 U.S.C. 351(a)(2)(B). The firm's November 8, 2024, response to the Form FDA 483 was deemed inadequate. Key violations include the failure to thoroughly investigate unexplained discrepancies or batch failures to meet specifications (21 CFR 211.192), specifically regarding repeated out-of-limit microbial content in their (b)(4) system, lacking sufficient root cause and CAPAs. Additionally, the firm failed to test samples of each component for identity and conformity with specifications (21 CFR 211.84(d)(1)) and failed to validate component supplier’s test analyses (21 CFR 211.84(d)(2)). Critical data integrity issues were noted, as the firm failed to exercise appropriate controls over computer systems (21 CFR 211.68(b)), with laboratory equipment lacking restricted access, unique user credentials, and adequate data backups, allowing unauthorized data deletion or modification. The FDA strongly recommended engaging a qualified CGMP consultant. The firm must respond within 15 working days detailing corrective actions and prevention plans. Failure to address these deficiencies may result in FDA withholding new application approvals, re-inspection, and refusal of admission for products manufactured at the facility into the United States.