Expectations or claims that the FDA is to assure safety are unfounded as per K. Watts analysis: "FDA has no legal obligation to conduct any tests for compliance or impose any enforcement measures...... the BLA/CMC (chemistry, manufacturing and controls) charade and its precursors back to 1902 is for the purpose of projecting the illusion, among the targeted population, that biomedical researchers and manufacturers have the physical ability to control ... and have the physical ability to design such mixtures to have therapeutic value.
The purpose of the pretextual documents is to instill irrational trust and override or block calm, rational assessment of the absurd scientific, technical and medical claims made by biological product purveyors."
The FDA is an illusion created to manipulate.
From There cannot be product liability exposure for manufacturers of products for which no physical, objective standards exist.
Katherine Watt Jun 2