1Labeling and packaging
The containers of your outsourcing facility's drug products does not include information required by section 503B(a)(l0)(B).
Inspection Record
Empower Clinic Services, LLC — FDA 483 Findings
Inspectors Camerson E MooreThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Regulatory reporting and change control
Your outsourcing facility has not submitted adverse event reports in 2019 FDA in accordance with the content and format requirements established through guidance (AE Reporting Guidance) or regulation under section 310.305 of21 CFR.
3Process validation
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
4Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
5Other quality system
Your firm 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).
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
About this record
Extracted automatically from the document US FDA published on 2020-05-04. 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.
