Key facts
| Firm | Fujifilm Diosynth Biotechnologies Texas, LLC |
|---|---|
| FEI / inspection ID | 3011948449 |
| Inspection end date | March 11, 2025 |
| Citation count | 8 |
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.
Citations explained
Observation 1 — Your mu lti-product manufacturing areas are not adequately controlled to prevent potential
Your mu lti-product manufacturing areas are not adequately controlled to prevent potential cross-contaminatio n. Specifically, a. There are no physical or procedural segregation controls for materials, equipment, an d personnel movements between upstream and downstream manufacturing areas. b. The clean room grade (CRG) areas lack s[pecified pressure differentials between upstream and downstream manufacturing suites for ~ intermediate, and parameters for air exchange rates for the CRG manufacturing suites have not been defined. c. There are no established standard operating procedures (SOPs) for managing shared processing areas for concurrent multi-product manufacturing operations. d. During inspection, it was observed that operators in the CRG and Grade C manufacturing suites frequently left~ ---- (bH-Of , pen for extended periods wit h_out covers. Th is . d I . ~ - . f • (b)<-O~ r----(6)1:l issue occu rre mu tip e times ctu n ng me connection o aseptic .----1 LO L___ ______(b_~... <41on .,..,...___,,,.......,.,.--=-___,,,_...,""' (b>< 4 and ~•H 4 Additio na ll.
Observation 2 — Your QC laboratory controls used for in-process, release, and stability testing ofj
Your QC laboratory controls used for in-process, release, and stability testing ofj (b)(4J intermediate do not include appropr ia te test procedures that assure conformanc_e_t.&n" appropriate standards of QUalitv and 4 c,uri ty. Specifically, t he' -=:.,j method for in -process testing of Cb>< ;in.termedi,rr te (b)<"~is n ot adequately verified or validated (b)(4J ~ CbT(41 -w for its intended use. You reported that_ l and ~ 1/o LJ ut between iJ (b)(4} (b)(~ . . . - of l}ests) ofl ....Jtests were mvahdated mainly ue o a1lecl system suitability criteria resulting from low% recovery of the lowest standard concentration. The lowest standard concentration for this method is also the limit of quantitation (LOQ) for the method, and is therefore, expected to have sufficient recovery. The recurring system suitability failures indicate that there is no assurance that the method is adequately validated and capable of consistently meeting system suitability criteria.
Observation 3 — The stabi lity program SOP "FDBT-SOP-0405 (revision 10)" is not being followed
The stabi lity program SOP "FDBT-SOP-0405 (revision 10)" is not being followed . The SOP requ ires that stability testing for internal tests be initiated within the te_s_t_initiatio_o windows (b)(41 indicated in Table 2 of Section 4.4.5.5. However, review of historical ]intermediate rstability sample pulling and testing schedules from January 2024 to l'vlarc n to·2~5 showed that the following stability tests were performed outside of the testing initiation windows specified in the SOP: CEX -HPLC analys is of,Jn1 Cb><4 ~:~(-20°C, 24-month time-point) performed 78 days past the testing window, lot (-20 °C, 24-month time-point) performed 92 days past the testing window, lo (b~~ 4~ -20 °C, 24 -month time-point) performed 107 days past the testing window, lot ..(-20°C and 5"C , 6-month time-point) performed 57 days past the testin1(Wm~crow1 CbJH4l(-20°C and 5°C , 9-month time- point) performed 24 days past the testing w1na ow ; and-S- - PLC analysis of lot [ Cb><4J (-20°C and 5°C , 6-month time-point) performed.
Observation 4 — Your cleaning and sanitization program is deficient in preventing potential contamination in
Your cleaning and sanitization program is deficient in preventing potential contamination in the controlled drug substance manufacturi ng areas. Specifically, a. The SOPs (FDBT-SO~r-0_682_ re\lisio~><1?; FDBT-Wl-0040, revision 12; FDBT-Wl-0347, revision 3) for Grade A; p peration and cleaning are inadequate in providing ex~licit instructions on post-use cleani ng . It was observed that only the outer surfaces of 41 the~ (b)( 4 :used to hold WCB vials and the cell viaar ilit sample cups were cleaned wit (b)( fwipes. However, the areas inside the (b)(4~which had direct contact with vials and cups, were not cleaned post-use. b. Your cleaning and sanitization procedure for the manufacturing areas in th~L t"Rj facility (SOP-0322, revision 21 .0) does not requ i re documentation and verification m the clean ing logbooks during the facility cleaning and sanitization that the treated surfaces are wetted and remain wetted for the contact time validated in the disinfectant efficacy studies. C. Your disinfectant efficacy study (Report# 22-137DET, approved.
Observation 5 — _Envlmnmeptal monitoring (EM) of classified processing areas in your[ (b><j acility for
_Envlmnmeptal monitoring (EM) of classified processing areas in your[ (b><j acility for the (b)( >j ntermediate manufactu rin g operations is deficient. Specif1car1y, . a. During the routine EM monitoring of the solution preparation activity room t n March 06, 20~5, a QC analyst was obs~rved usi ng inadeq_uate sa~pl i ng techniqu~ er (b)(4 1 plate did not make full contact with the surfaces while the viable samples were colle-cnm. b. There is no EM sampling for th ~ operation. SEE REVERSE OF THIS PAGE El.IP.~• ~~~~~(>"'-~-- < fe-•1,;!~ (<M>
Observation 6 — Your fir~ faited to exercise appropriate controls for the electronic data acquisition
Your fir~ faited to exercise appropriate controls for the electronic data acquisition systems used forl Cb>< 4 ~intermediate manufacturing. Specifically, r (b)(4l ~m a. Th ere is a lack of documented evidence that the,_____~-- ~ystems and the [ CbTC~system have been validated to pr~ ect onginalefectronic records an rerevar l Cmetaaata (e.g ., audiLt rails) J hese svste.rns are uJilized to collect and process data4 from data loggers during theL__ Cb>< jvalidation of critical process ~ .uipm? r:,t and systems at your faciliiy,Trici'uclTng ,- -~---.---- Cb>14 ) L :J in addition, audit trail review-is not performecrtor eac fia atasetouring the valicfat1on review. During data review, only final printouts of the measurement results are reviewed , and they are not verified against the original electronic records . b. Your firm lacks an adequate program for comprehensive evaluation of the ,..[---.(6,~ ~..§.tern audit trails to identify and address any aberrant trends associated with user-aborted L Cb><j sequen ces/injections/sample-sets events. Specifica ll y,.
Observation 7 — SOPs or work instru ctions are not fo ll owed or are
SOPs or work instru ctions are not fo ll owed or are inadequate. Specifically, a. The instructions in the QC release and stability test methods are deficient to en sure conformance to appropriate standards of quality and purity. For example, 1. c::: ::.M 022-6.J Cb><1,A nalysis of Cb><4 i(revision 7) . The! Cb><4 ;method is used for in-process, release, and y ing.'"there are specific sections of FDBT-TM-0226 that provide instructions (_C--0 -;,r Yan yan Cao, Ph .D., Pharmaceutical Scientist EMPLOYEE($) SI-G~1 ,RE ~ \ f MPI.OYE:E.{S) NAME ANO TITLE (Pri,,t or TypeJ OATE I SS UED _e,;.-.7,Y~r_'-;>~ Jie He, l e ad , Senior Reg ula tory Specialist SEE / Zhong Li , Ph. D., Se nio r Regula tory Specialist R5:~~!E PAGE A A ,(A' . ., f V l..rC' (jl_, .. , ov.N().,/_,, -·;(._(?..- ~c;,(J,,.,v ' V fta,..... .,,.,."',;I "' """ /'-· M ercy Oyugi, Ph. D., Se ni or Ph armaceut ical Sc ientist Ayyapp an Ra.
Observation 8 — (b)(~
(b)(~ . intermediate batch re cords at FDBT are The intermed iate hold times defined in the inconsistent with the hold times defined in Lf 1 (b)(4' fo r l UH "1s spe ci fi ed in the Specifically, an intermediate hold time of ~ thd - Er~~ 37-vSEE REVERSE OF THIS PAGE W @tw v' · r,,.,..J,,_ (p..,
Fujifilm Diosynth Biotechnologies Texas, LLC’s FDA history
Argus HQ has recorded 1 total FDA action tied to Fujifilm Diosynth Biotechnologies Texas, LLC: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3011948449.
- 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.
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Related enforcement actions
Full FDA history for Fujifilm Diosynth Biotechnologies Texas, LLCCompiled 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). FDA Form 483 — Fujifilm Diosynth Biotechnologies Texas, LLC (March 11, 2025) — 8 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-fujifilm-diosynth-biotechnologies-texas-llc-2025-03-11-3011948449
"FDA Form 483 — Fujifilm Diosynth Biotechnologies Texas, LLC (March 11, 2025) — 8 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-fujifilm-diosynth-biotechnologies-texas-llc-2025-03-11-3011948449.
Argus HQ Research. "FDA Form 483 — Fujifilm Diosynth Biotechnologies Texas, LLC (March 11, 2025) — 8 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-fujifilm-diosynth-biotechnologies-texas-llc-2025-03-11-3011948449.
@misc{argushq_argushq_ai_483_fda_483_fujifilm_diosynth_biotechnologies_texas_llc_2025_03_11_3011948449_2025,
title = {FDA Form 483 — Fujifilm Diosynth Biotechnologies Texas, LLC (March 11, 2025) — 8 Citations},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-fujifilm-diosynth-biotechnologies-texas-llc-2025-03-11-3011948449},
note = {Accessed: July 15, 2026}
}