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5 Observations from Cook Pharmica Inspection
09/13/2018
 

A FDA-483 issued following a 4/23-4/27 and 4/30-5/1 inspection at Cook Pharmica, Bloomington, IN, has five inspection observations. They are: 

  •          there is an unacceptably high number of mold recoveries in the classified rooms for manufacture of a redacted bulk drug substance;
  •          written procedures to prevent contamination of a redacted drug substance are not followed;
  •          there is a lack of quality oversight in the review of records and procedures followed in drug substance manufacture;
  •          corrective actions do not include implementation of adequate procedures to prevent similar deviations from recurring; and
  •          sufficient controls to prevent unauthorized changes to data stored on the firm’s computer systems are inadequate.


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