FDA EIR - Halo Pharmaceutical, Inc. d/b/a Cambrex Whippany - December 20, 2019

An FDA inspection of Halo Pharmaceutical, Inc., also operating as Cambrex Whippany, was conducted from December 9 to December 20, 2019. This comprehensive GMP and pre-approval inspection covered quality, laboratory control, production, and material systems, including coverage for ANDA 213438, Hydroxyurea Capsules USP 500mg. The inspection resulted in an FDA Form 483, detailing significant observations. Main violations included the failure to follow procedures for warehousing drug products, specifically regarding the proper control, accountability, and storage or destruction of materials under investigation. Furthermore, the quality control unit did not fully adhere to its written responsibilities and procedures, with numerous investigations failing to close within the mandated 30-day timeframe or without proper extension documentation, violating 21 CFR 211.22(d). Additional issues identified involved deficiencies in data integrity, such as unintegrated or unevaluated unknown peaks in HPLC data for product testing, and an inadequate, non-procedure-driven audit trail review process for laboratory software. The firm also deviated from stability protocols without initiating proper deviation reports and exhibited inconsistent product handling practices, including operators touching drug products with bare skin or gloved hands without proper glove changes, and wearing jewelry in GMP areas. Equipment cleaning procedures were found to be insufficient, and a planned deviation for a sterile filling line was not fully documented or consistently followed. Halo Pharmaceutical management acknowledged the findings and committed to submitting a written response to the FDA 483 observations within 15 business days, with some immediate actions indicated for specific issues.