1Aseptic processing and sterility assurance
Clothing ofpersonnel engaged in the compounding ofsterile dmg products is not appropriate for the duties they perform.
Inspection Record
Region Care, Inc., — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Labeling and packaging
The labels for the drug products do not contain information required by section 503B(a)(l 0).
3Aseptic processing and sterility assurance
Each batch ofdl'Ug product purporting to be sterile and pyrogen-free is not laborat01y tested to determine conformance with such requirements.
4Material and supplier control
Written procedures are lacking which describe in sufficient detail the receipt, identification, storage, handling, sampling, testing, approval, and rejection ofcomponents, drug product containers, and closures.
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.
