Inspection Record

AnazaoHealth Corporation — FDA 483 Findings

US FDAInspected 2019-09-19Published 2019-11-27 3 findingsRegulatory reporting and change controlEquipment and facilityAseptic processing and sterility assurance

Inspectors Zachery L MillerThe inspectors who signed the published document.Inspector lookup

View the regulator's official source The source document is always the basis for judgement.

Findings

1Regulatory 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 of the FDCA as required by section 503(a)(2)(C).

2Equipment and facility

( The flow of components, drug product containers, closures and in-process materials -through the building is not designed to prevent contamination.

3Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.

About this record

Extracted automatically from the document US FDA published on 2019-11-27. 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.

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