Firm Record

Bio-Thera Solutions, Ltd. findings history

6 findings from 2 inspection documents published by regulators. Each row below says what its date means.

EMA (Europe)US FDA 2026-05-06 ~ 2026-06-12 2 documents 6 findings

Areas cited

Computer system validationProcess validationAseptic processing and sterility assuranceLaboratory and QC controlsQuality unit oversight

Published inspection documents

2026-06-12 EMA (Europe) 1 findingsComputer system validation This NCR is limited to the drug product manufacturing activities related to the 4 products: - Usymro® (Ustekinumab) 45 mg and 90 mg, solution for injection and Usymro® (Ustekinumab) 130 mg, concentrate for solution for infusion (vial and pre-filled syringe presentations); - Avzivi® (Bevacizumab) 25 mg/mL concentrate for solution for infusion (vial presentation); - Tofidence® (Tocilizumab) 20 mg/mL concentrate for solution for infusion (vial presentation); - Gotenfia® (Golimumab) 50 mg and 100 mg solution for injection (pre-filled syringe presentation). The inspection raised 33 deficiencies including 1 critical deficiency and 8 major deficiencies related to drug product manufacturing activities. One critical deficiency was raised: 1) Failure to investigate and assess product impact in the deviations including deviations related to Aseptic Process Simulation (APS) failure and environmental monitoring excursions in grade A/B cleanrooms. Eight major deficiencies were raised: 1) Failure to have efficient cleaning and disinfection practices of cleanrooms, as well as material transfer processes to grade A/B areas, by using practices that were not conducive to minimizing microbial contamination; 2) Failure to have suitable manual visual inspection process of filled units by deviating from Eur. Pharmacopeia requirements and from qualification data of manual inspection tables; 3) Failure to requalify cleanroom for the prefilled syringe filling room in accordance with Annex 1 of EU GMP; 4) Failure to implement cleanroom environmental monitoring program fully in accordance with Annex 1 of EU GMP; 5) Failure to adequately manage particle contamination on 200 L single-use storage bags (used during vial filling of Avzivi® and Tofidence®) by modifying the manufacturing process to include a 3 µm filter after the final sterilizing filtration 0,22 µm; 6) Failure to adequately define the aseptic interventions for the annual requalification of operators of filling lines as well as acceptance criteria during the initial qualification of the QC employees for APS reading; 7) Failure to manage computerized systems in the QC lab in accordance with Annex 11 of EU GMPs requirements; 8) Failure to establish approved quality agreements with Marketing Authorization Holders and Importers. Action taken/proposed by the NCA: Withdrawal, of current valid GMP certificate No. 2024_HPF_PT_003_NA / Prohibition of supply No batch of the 4 products manufactured prior to the issuance of this NCR and manufactured while this NCR is in force should be supplied to Europe. 2026-05-06 US FDA 5 findingsAseptic processing and sterility assurance · Process validation · Laboratory and QC controls · Quality unit oversight · Computer system validation Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not fully established or followed.

About this page

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.

What is included. As of 2026-09-03, only documents that have a detail page (at least 3 findings) are listed. The company may have more documents; the full set is available in Company lookup below.

Companies are grouped by a normalised key, not the displayed name — “… Limited” and “… Ltd.” count as the same company. Translation and classification are automated and may differ in nuance from the source; the basis for judgement is always the regulator's published document.

Full history of Bio-Thera Solutions, Ltd. — including inspection classifications Browse by document Go to Findings search