1Labeling and packaging
The container of your outsourcing facility's drug products is missing the container label and does not include information required by section 503B(a)(l 0)(B).
Inspection Record
Apollo Care LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Labeling and packaging
The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(l0) (A).
3Other quality system
Drug products are not stored under appropriate conditions of light so that their identity, strength, quality, and purity are not affected.
About this record
Extracted automatically from the document US FDA published on 2023-07-13. 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.
