Factory Inspection Amendment

The Factory Inspection Amendment clarifies FD C and requires FDA to provide written inspection... 

Factory Inspection Amendment required FDA to give manufacturers written reports of conditions noted during inspections. 

The Durham Humphrey Amendment (1951) defined the kinds of drugs that required medical supervision for safe use and restricted them to sale by prescription. Two years later, in 1953, the US Public Health Service issued a policy document entitled Group Consideration of Clinical Research Procedures Deviating from Accepted Medical Practice or Involving Unusual Hazard. This policy stated that the potential risks of clinical studies must be carefully assessed and that informed consent was essential. Ethical review of research proposals was also suggested. In this same year, the Factory Inspection Amendment was passed, requiring the FDA to give written inspection reports to manufacturers. 

Which act or amendment granted the FDA the authority to inspect factories ... 

---