FDA WARNING_LETTER - Shandong Analysis and Test Center - January 18, 2017

The FDA issued a Warning Letter to Shandong Analysis and Test Center following an inspection from January 16-18, 2017, identifying significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API), rendering their API adulterated.

Key violations include: 1. **Failure to ensure scientifically sound test procedures:** The facility, a contract testing lab for heparin and heparin-related drugs, failed to routinely establish system suitability for over-sulfated chondroitin sulfate (OSCS) testing using Nuclear Magnetic Resonance (NMR) spectroscopy. A failed system suitability test on December 26, 2014, was not investigated, nor was the reliability of prior tests determined. The company's response acknowledging infrequent system suitability and committing to future routine testing was deemed inadequate for not investigating the validity of past test results. 2. **Failure to prevent unauthorized data access/changes and ensure data integrity:** The quality control unit lacked controls to prevent changes to electronically-stored laboratory data. An analyst admitted to deleting older data to free space. The company's commitment to revise computer permission levels was insufficient as it did not address the deleted data. 3. **Refusal to provide information during inspection:** The facility provided a customer list but withheld sample information and test results for most customers, citing a need for prior consent. This included data for a firm supplying the U.S. heparin market. Such refusal can deem drugs manufactured at