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Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Lack of Assurance of Sterility
Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
Defective container: Cracked vials leading to lack of sterility assurance
Failed Dissolution Specifications: results were above specification.
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Failed Impurities/Degradation Specifications; out of specification for Related Compound
Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"
Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.
Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts.
It was discovered that bottles of Brain and Memory Power Boost was filled with multi vitamin-mineral product - NeuroVite Plus
Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
Failed Impurities/Degradation Specifications