1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not fully established or followed.
Inspection Record
Bio-Thera Solutions, Ltd. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Process validation
Written procedures for production and process controls designed to assure that the drug product has the identity, strength, purity, and quality that they are purported or represented to possess are not fully established or followed.
3Laboratory and QC controls
Laboratory controls do not include the establishment ofscientifically sound and appropriate standards designed to assure that components and in-process materials confonn to appropriate standards of identity, strength, quality, and purity: e),f)LO'fEE1S) s,:;;N,\ Tl.RE ~j -1/J, };...
4Quality unit oversight
The responsibilities and procedures applicable to the Quality Unit are inadequate: A.
5Computer system validation
Adequate procedural controls were not established to protect the electronic data acquisition and process control systems used for the manufacturing ofj (b)(4ps and DP in your manufacturing facility.
About this record
Extracted automatically from the document US FDA published on 2026-05-06. 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.
