1Material and supplier control
There was a failure to handle and store components and drug product containers at all times in a manner to prevent contamination.
Inspection Record
Exela Pharma Sciences LLC — FDA 483 Findings
Inspectors Rachael A MoliverThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Labeling and packaging
Strict control is not exercised over labeling issued for use in drug product labeling operations.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
4Other quality system
The results of the examination of the packaged and labeled products were not documented in the batc h production or control records.
5Labeling and packaging
The labels of your outsourcing facility's drug products are deficient.
6Equipment and facility
Routine checking of electronic equipment is not performed according to a written program designed to assure proper performance.
About this record
Extracted automatically from the document US FDA published on 2019-12-09. 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.
