Zhong Li, Ph.D., SPQA, OPQ/OPMA/DBM1 Goal Date July 24, 2021 Recommendation for Approvability: This BLA was reviewed from a product quality microbiology perspective and sterility assurance...

Zhong Li FDA Investigator Report. Designation: CHEMIST. Duty Station: Silver Spring MD 20993-0002. Organizations: DHHS FDA CDER OMPT CDER OPQ OPF DIA IABI. Total Inspections: 41. Total 483s Issued: 38. Total Warning Letters Issued: 0. Inspection Details. Longest Inspection: 16. daysShortest Inspection: 3. daysAverage Length of Inspection: 7.9. days

Belantamab mafodotin is a humanized, afucosyated immuno-conjugate that is specific for B-cell Maturation Antigen (BCMA). The antibody is conjugated to a microtubule disrupting agent monomethyl...

SB11 (ranibizumab-nuna; Byooviz) is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment designed for intraocular use that has been developed as a proposed biosimilar to...

Nov 13, 2023 · Zhong Li is a Senior Pharmaceutical Quality Assessor at U.S. Food & Drug Administration based in Silver Spring, Maryland. Previously, Zhong was a Senior Chemist at Fda and also held positions at Merck KGaA, AZ Electronic Materials, Merck. Read …

Zhong Li adopts a detail-oriented approach, focusing on regulatory compliance, cleanliness, and GMP manufacturing operations. He emphasizes the importance of effective oversight and procedural controls.

Feb 12, 2014 · Menthol is a monocyclic terpene alcohol, either derived from natural sources or synthesized. It can exist as one of eight stereoisomers, each of which has distinct pharmacologic...

Get Zhong Li's official FDA inspection documents. Gain valuable insights from their Form 483s and EIRs to ace your next inspection.