1Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
Inspection Record
Jiangsu Intco Medical Products Co., Ltd — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Process validation
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
3Material and supplier control
Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed, Specifically, Drug components used in the manufacture of QAI oducts lack identification testing.
4Material and supplier control
Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
About this record
Extracted automatically from the document US FDA published on 2026-07-09. 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.
