FDA WARNING_LETTER - Shandong Vianor Biotech Co., Ltd. - May 10, 2017

The FDA issued a Warning Letter to Shandong Vianor Biotech Co., Ltd. following an inspection from May 8-10, 2017, identifying significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals (21 CFR, parts 210 and 211). The firm's drug products are deemed adulterated under section 501(a)(2)(B) of the FD&C Act.

Key violations include: 1. **Falsification of laboratory records:** Management admitted to falsifying analytical test results for (b)(4) (lot (b)(4)) released to the U.S., violating 21 CFR 211.194(a). 2. **Inadequate quality control unit:** The quality unit manager admitted to reporting passing results on a Certificate of Analysis (CoA) for a subpotent batch of (b)(4) (lot (b)(4)), violating 21 CFR 211.22(a). 3. **Failure to maintain equipment:** The investigator observed rusted, corroded, and contaminated product contact surfaces on equipment, violating 21 CFR 211.67(a).

Additionally, the firm initially barred the investigator from a room identified as a laboratory and later claimed the actual laboratory was offsite and inaccessible, which may deem drugs adulterated under section 501(j