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# 5 Observations from Cook Pharmica Inspection
- URL: https://www.fdaweb.com/5-observations-from-cook-pharmica-inspection/
- Published: 2018-09-13T12:00:00.000Z
- Updated: 2026-09-15T00:31:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142353

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](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM619908.pdf?ref=fdaweb.com). 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.