Among a range of issues, the FDA's inspectors say they found evidence of poor cleaning procedures throughout the facility and substantial gaps in written procedures and training for workers at the plant. Scrutinizing the company's records also turned up unexplained discrepancies.
During one walk-through, an inspector"saw a black, brown greasy deposit" on part of one of the company's machines to fill its product into bottles. Logs claimed the machine had been cleaned just weeks before and had not been used since. Some key tests to double check that products coming off the company's lines were sterile were never done, the agency found, while others that had actually been performed were never validated.
The company also fell short of double checking the ingredients it used to produce its products, instead relying on assurances from their suppliers.
They blinded and killed people just to increase profits. When are they dragged off to a courthouse facing murder charges?
weeser1 Republicans -- Let's cut the FDA staff & budget. This company needs more space to get things right.