1Labeling and packaging
The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(10)(A).
Inspection Record
Cantrell Drug Company — FDA 483 Findings
Inspectors Scott T Ballard · Camerson E Moore · Sara RothmanThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Complaint and recall handling
Complaint procedures are deficient in that they do not include provisions that allow for the review to determine if the complaints represent serious and unexpected adverse drug experiences which are required to be reported to FDA.
3Deviation, CAPA, and investigation
Investigations of an unexplained discrepancy did not extend to other drug products that may have been associated with the specific failure or discrepancy.
4Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
5Material and supplier control
Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
6Other quality system
You compound drugs that are essentially a copy of one or more approved drugs within the meaning of sections 503B(a)(5) and 503B(d)(2).
7Regulatory reporting and change control
Your outsourcing facility has not submitted a report to FDA identifying a product compounded during the June 1, 2017, through November 30, 2017, reporting period as required by section 503B(b )(2)(A).
About this record
Extracted automatically from the document US FDA published on 2024-01-17. 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.
