1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Inspection Record
AnazaoHealth Corporation — FDA 483 Findings
Inspectors Eileen A. Liu · Lucila B. NwatuThe 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
Bulk drug substances used by your outsourcing facility to compound drug products are not each manufactured by an establishment that is registered under section 510 as required by section 503B(a)(2)(C): Specifically, On 01/22/2014, the following bulk drug substance manufacturers w...
3Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed.
4Labeling and packaging
The labels and containers of your outsourcing facility's drug products, do not include information required b y section 503B(a)(10)(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.
