FDA 483 - Biochem Laboratories, Inc. - July 24, 2025

During an inspection conducted from July 22-24, 2025, the FDA issued a Form 483 to Biochem Laboratory, Inc., a contract testing laboratory located in Lyndhurst, NJ. The inspection identified significant deficiencies in the firm's laboratory controls, particularly concerning data integrity and record-keeping, indicating non-conformance with appropriate standards for identity, strength, quality, and purity of drug products and materials.

Key observations included the firm's failure to adequately review electronic analytical raw data and audit trails from instruments used for testing pharmaceutical raw materials and drug products. There was also an absence of formal procedures governing these critical review processes. Furthermore, an analyst demonstrated the capability to permanently delete analytical data from a UV spectrophotometer without requiring supervisory approval or documented justification, highlighting a severe data integrity vulnerability. Records for two analytical balances were found incomplete, making it impossible to trace printed weight data back to the specific balance used. Lastly, the firm failed to adequately perform and record balance calibrations to the required decimal places, an issue previously observed in a 2019 FDA inspection.

Biochem Laboratory, Inc. is expected to address these observations by implementing robust corrective actions, including establishing scientifically sound specifications, improving data review processes, enhancing data security, ensuring complete record traceability, and rectifying calibration procedures to meet regulatory expectations under the Federal Food, Drug and Cosmetic Act.