1Equipment and facility
All major equipment used during the production ofa batch ofdmg product is not properly identified at all times to indicate.
Inspection Record
Fujian Genohope Biotech Ltd — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Process validation
Your fnm failed to establish adequate written procedures for production and process controls designed to assure that the diug products have the identity, strength, purity, and quality that they are purpo1ied or represented to possess.
3Equipment and facility
Equipment used in the manufacture, processing, packing or holding of dmg products is not of appropriate design, ofadequate size and suitably located to facilitate operations for its intended use.
4Material and supplier control
Written procedures are not followed for the receipt, identification, storage, handling, sampling, testing, approval and rejection of components, drng product containers and closures.
5Process validation
Written production and process control procedures are not followed in the execution ofproduction and process control functions.
About this record
Extracted automatically from the document US FDA published on 2026-03-03. 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.
