Key facts
| Firm | Bio-Thera Solutions, Ltd. |
|---|---|
| FEI / inspection ID | 3017231337 |
| Inspection end date | January 17, 2025 |
| Citation count | 5 |
Citations explained
Observation 1 — Procedures designed to prevent microbiological contamination of drug products purporting to be
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not fully established or followed. Specifically, A. Aseptic techniques aimed at maintaining sterility of sterile items and surfaces are not used at all times. 1) Sterile materials are not always handled with sterile tools. For instance, • • f, j (b)(4J,fill' • I :) i. Durmg equipment setup or1 J I ml operation (b)(4~ a!~~ #c (b)(4 j 0l/09/2025), non-sterile (b)(A~were used to remove! (b 4 ~covers for the( oprr bowl and stopper chute. 4 ii. During equipment setups for (b)( ' nd vial filling operations L fl (h) (4) Batch #I (b'14 ~01/09/2025 and! (b)(4~drug producfl (bH4i ial Batch # (b)(4 IO1/10/2025), sterile scissors were placed on the non-sterile surfaces in the RABS. The scissors were subsequently used to cut open~ bags containing sterile parts such as stoppers and I (h)(4) In addition, this was observed during review of dynamic air flow visualization study videos.
Observation 2 — Written procedures for production and process controls designed to assure that the
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. Specifically, '0 A. I (b)(j are perfonned forl "•:ct~g__11roduct manufacturing. According the PPQ batch records, for example, size~ (b)(~and ~ g~(b><4J,m L, Batch size: (b)(4) C (b)(4), d . I L -~ (liJ ~ere taken 10 ......,_-,-__,,.......'an testing samp es were taKen rrom th\ ___ 1 4 Cb>< >stages of the batch productions. The current[ (b)( 4 ) ampling plan including t fle .,_n_u_m_b-er...of samples do not provide a statistically sound representation of the C ~ filled in the batch productions. B. Appropriate visual inspection (VI) procedures designed to assure batches otj CbH 4 Jproduct meet appropriate specifications and statistical quality control criteria are not established. I) 100% visual inspection o f! (b}(4]~ nd the acceptance testing (AQL testing) are performed in the packaging room.
Observation 3 — Adequate procedural controls were not established to protect the electronic data acquisition
Adequate procedural controls were not established to protect the electronic data acquisition and process control systems used for the manufacturing of j (b)(4ps and DP in your manufacturing facility. Specifically, A. Reviews of electronic data including audit trail information are not performed by the Quality Assurance (QA}unit for manufacturing equipment prior to the final approval of manufacturing_ batch SEE REVERSE OF THIS PAGE e MP\.O'fEE(S) SGlllA.TLIRE .frl((-:.;, IV', 1 / • ~ / ',/~,'..,~ \ ' 31Sr j J,t#r f-?
Observation 4 — The resp onsibilit ies and procedures appli cable to the Quality Un
The resp onsibilit ies and procedures appli cable to the Quality Un it are inadequate: A. The Quality Unit failed to fo llo w the deviation management SOP, 2-SMP-L (b><4} oso (5.0), by not including the recordab le event RE202401 I in me dia fill report VR-PV-A-009 (03). B. The Alert Limit and Action Limit Management Procedure SOP, 2-SMP{ (b)(4}015 (8.0), a ll ows alert limits to be adjusted with a CAPA that doe s not require a risk assessmen t. CAPA 2-SMP~ F,o77-R02 (4.0) was approved for loosening the requirement to investigate mold from (m:; FU E} ] (b)(4J covery to greater tha~ FUf (bH 4J ecovery in Grade C and D areas. C. The deviation management procedure, 2-SMP-~ 080 (5.0), is inadequate: 1) lt d oes not req uire a CAPA fo r excursi ons for which " the cause is clear". For example, a CA PA was not opened fo r recordable event RE2024011 when the particle.
Observation 5 — : Laboratory controls do not include the establishment of scientifically so und
: Laboratory controls do not include the establishment of scientifically so und and appropriate sta ndard s designed to assu re that components and in-proc ess materials confonn to appropriate standards of identity, st re ngth , quali ty, and p ur ity: e),f)LO'fEE1S) s,:;;N,\ Tl.RE ~j -1/J, };pv~L- SEE REVERSE OF THIS ' PAGE rr,~I rh ho EMPt.O "l'EE(S ) NAWE ANO TliLE (P/.tiror Type} OATE ISSl.EO Yiwei Li, Pt,.0., Supervisory Chemist Jeanne Fri nger, Ph.D., Chemist No zo mi Sakakibara, Ph .D. Senior Research Scientist 01/17/2025 Jiangsong Jiang, Ph.D. Pharma ceut ica l Sc ientist
What a Form 483 means
A Form FDA 483 is issued at the close of an FDA facility inspection to list conditions an investigator observed that may violate the Federal Food, Drug, and Cosmetic Act or its implementing regulations. It reflects the investigator's professional judgment at that point in time and is not a final agency determination, an enforcement action, or proof that a violation occurred. Firms are expected to respond in writing, typically within 15 business days, describing the corrective and preventive actions they plan to take. FDA reviews that response, along with any follow-up evidence, before deciding what happens next. Many 483s are resolved through corrective action alone. When FDA judges a firm's response inadequate, or when the underlying conditions are serious enough, the observations documented here can lead to a Warning Letter or further regulatory action. This page presents the observations exactly as recorded on the FDA-issued document; always confirm citation language against the original record before relying on it.
Bio-Thera Solutions, Ltd.’s FDA history
Argus HQ has recorded 1 total FDA action tied to Bio-Thera Solutions, Ltd.: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- Is a Form 483 the same as a Warning Letter?
- No. A Form 483 lists an FDA investigator’s observations at the close of an inspection; it is not a final agency determination. FDA may or may not follow up with a Warning Letter depending on the firm’s response and the severity of the findings.
- Where can I read the full Form 483?
- The verbatim inspection record is the source of truth — always confirm citation language against the original FDA document before acting.
- What is an FDA Form 483?
- A Form FDA 483 lists an FDA investigator's written observations at the close of a facility inspection, issued under section 704(b) of the Federal Food, Drug, and Cosmetic Act. It documents conditions the investigator judged may violate FDA regulations. A 483 is not an enforcement action or a final determination that a violation occurred.
- Does this Form 483 mean Bio-Thera Solutions, Ltd. violated the law?
- No. A Form 483 documents an investigator's observations only. FDA reviews the firm's written response and any corrective actions taken before deciding whether further action is warranted, and many 483s are closed without additional enforcement once a firm shows adequate correction.
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Related enforcement actions
Full FDA history for Bio-Thera Solutions, Ltd.Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2025). Form 483 Record: Bio-Thera Solutions, Ltd., January 17, 2025 — 5 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-bio-thera-solutions-ltd-2025-01-17-3017231337
"Form 483 Record: Bio-Thera Solutions, Ltd., January 17, 2025 — 5 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-bio-thera-solutions-ltd-2025-01-17-3017231337.
Argus HQ Research. "Form 483 Record: Bio-Thera Solutions, Ltd., January 17, 2025 — 5 Citations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-bio-thera-solutions-ltd-2025-01-17-3017231337.
@misc{argushq_argushq_ai_483_fda_483_bio_thera_solutions_ltd_2025_01_17_3017231337_2025,
title = {Form 483 Record: Bio-Thera Solutions, Ltd., January 17, 2025 — 5 Citations},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-bio-thera-solutions-ltd-2025-01-17-3017231337},
note = {Accessed: July 13, 2026}
}