1Other quality system
Your firm released drug product in which the strength differs from, or its purity or quality falls below, that which is purports or is represented to possess.
Inspection Record
Crawford’s Professional Drugs, Inc. dba Diket’s Professional Drugs, Inc. — FDA 483 Findings
Inspectors Joanne E KingThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Contamination control
You produced hazardous drugs without providing adequate containment, segregation, cleaning of work surfaces, cleaning of utensils and cleaning of personnel to prevent cross contamination.
3Contamination control
Personnel did not change gloves frequently gloves enough to prevent contamination.
4Equipment and facility
Your facility was designed and/or operated in a way that permits poor flow of personnel and materials.
5Contamination control
You produced highly potent drugs without providing adequate containment, segregation, cleaning of work surfaces, cleaning of utensils and cleaning of personnel to prevent cross-contamination.
About this record
Extracted automatically from the document US FDA published on 2019-04-30. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
