FDA EIR - Union Carbide Corporation - August 21, 2014

An FDA surveillance inspection of Union Carbide Corporation's Hahnville, LA facility occurred from August 19-21, 2014. Conducted under the Active Pharmaceutical Ingredient Inspection Program (C.P. 7356.002F), the inspection focused on the manufacturing of polyethylene glycol (PEG), an active pharmaceutical ingredient. While no FDA Form 483 was issued, several critical observations were discussed with company management.

Key issues identified related to laboratory and quality control practices. The company lacked routine calibration and a written schedule for its High-Performance Liquid Chromatographs (HPLCs), essential for product testing. A voided laboratory result for an HPLC test lacked adequate documentation, and concerns were raised regarding the inappropriate alteration of data with correction fluid rather than re-running the sample, suggesting potential data manipulation.

Additionally, deficiencies were found in metal detector verification records for packaged products, including missing review signatures, absence of actual operational data, and an unperformed check on a specific date. Packaging records also showed non-contemporaneous alterations, where data was changed retrospectively.

Although no formal regulatory action was initiated, Union Carbide was advised to establish a scientific-based calibration schedule for laboratory equipment, improve documentation for all lab results, particularly voided ones, and ensure accurate, contemporaneous record-keeping for metal detector verifications and packaging operations. These actions are crucial for maintaining compliance with good manufacturing practices.