Key facts
| Firm | Alvotech Hf |
|---|---|
| FEI / inspection ID | 3013702557 |
| Inspection end date | July 4, 2025 |
| Citation count | 10 |
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 firm failed to establish written procedures for production and process controls
Your firm failed to establish 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 rep re sented to possess. Specifi ca ll y, (tif(4J .-------(bH4l Per SOP-0 83 2 J ppl1cat1on F illing Equipment" (version 5 0, effective 04 Apr 00 2024 ), '"""s app hed to ~ ct pmd uct- contact stopper delivering h" "'"ltono eJJD.a..oa 1nd.ud~ (b)(4)- (bTC~ sed during the fi ll ing and stoppering of ~ e not provided adequate data and scient1Ic JUS 1Ica 10n o emons ra e a Is (b)(4}i pplica ti on is consistently co ntroll ed and would not adv er sely impact product quality anasta15iTity.
Observation 2 — The responsibilities and procedures applicable to the quality unit are not fully
The responsibilities and procedures applicable to the quality unit are not fully follow ed . Specifically, A. Since January 2025 y ou re..c.el\lad...15.9 c_o(Tlpla ints for associated wit t (bH4you identifi 1:rcr'n1ncrea seorren a ror W<j reduct com laints with s 1m1 Iar_~om pla1nts categp riLe.d...as (bH (bH4} (b)(luse error)" andL 1 and trended separately. You did '"'n"'o,.,..,:,,:r""o'"'v ""'1 ""e'""'s""c""1e"'"n,,,.,.,,, ""1c,...J""u"'s""1t,...1c""'a""'t,.,1o"'n'"'for trendin th~se complaints separately or documentation defining a WC 4J ompla in t, (ti) (4J; omp laint or how user error is determined. A oug none o these comp am ca egones reached the upper control limit (UCL) of natu ral variation when analyzed individu ally , the UCL was exceeded when the complaints were analyz ed toge th er . No evidence was provided that this upward trend was evaluated pri or to 23 Jun 2f 25J no CAPA was~se.d ~9U~03 Jul 2025, and no supplier inves ti gati on has been opened with the (bH 4 supplier.
Observation 3 — There is a lack of assurance that your drug substance and drug
There is a lack of assurance that your drug substance and drug product manufacturing operations are appropriately designed to ensure the prevention of contamination of equi pment or product by environmental and processing conditions that wou ld be expected to have an adverse effect on product quality. Specifically, A The microbial controls of your DS manufacturing process are deficient. For example, C i. You do not h. ave adequate microbial control of vou~ {tiff4!i.mit oper~ati on. Tw~nty QLb.Loburd !;ln excursions inl (b)Jintermediates in {6JC4Iand (b) 4 viral inactivation unit operations were 1dent1fiecJ'iilP Q <;1nd post-PPQ oatcnes.~ . dd1t1on aiiy, nin r.£>..a...(1.9.Lhlobu~~~ failu~es were observeF (b)C4!<.ar:onl e.s i.od11.di~ff.~ after storage, for sed In manufacture of products. ii. r 'Cau..&farded evidence of filamentous fungi recovery from the product stream of C (bY{,4~n d I I SEE REVERSE OF TH IS PAGE □ al~ I s~tcb I f MPl,O E1 $) SIGNATURE ~ --:::::=----- ~' I A~ ~'--' , :7 Pv I/ S:>.o;,.ille.
Observation 4 — 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 established and followed. Specifically, A. Wh;le obsecv; \;h;~p uc setup and fimn !UJle, aUons on thi ,,;;,;mn Une fg, th e m ~c~ure o (4J P product Batch # L_ >)l4'{on 01 1: and CbH4 > P Batch# 4 (1i <)(on 2025), the following deficiencies in the aseptic processes were noted: ..i-. _ D_u_n-.n-g...the """'-==..,,..,..,,., CbT<4'oro__c~th.e CbT<4'portion of th iJ( 4 L nit disrupted the first air above t CbH(puosequentl y, the Cbn4 low units within the Restricte Access Barrier ystem (RABS). --------- amInar aI ii . During installation of the filling and .tono.emo..s.tatioos~ the operator was observed handlin unprotected sterile parts, including CbH4lcollect io n hoses, and Cb)l4l Cb>~ar his gloved hands. These components are positioned directly above t e expose Cb f nd product during the filling and stoppering process. iii . ,_D_u_r-in_g_, (liH"lube installation, the operator's gloved hand and non-sterile Cb)C4ld1s rupted.
Observation 5 — Written records of unexplained discrepancies or the failure of a batch or
Written records of unexplained discrepancies or the failure of a batch or any of its components to meet specification, do not always contain a thorough investigation, or appropriate documentation, conclusi ons, and fo ll ow-up. Specifica ll y, A. You im plemented a QMS update for management of OOS/OOE events and associated manufacturing investigations under one laboratory investigation ( Ll -xxxx) reco rd on 10 Jul 2024. As a result, in deviation from your SOP-0922 v. 18 , devia ti on records {DEV-xxxx) are no longer opened for unplanned departures from specification, acceptance criteria or other conformance standards confirmed by your initial laboratory investigation. M~gJ.JJ_i no investigations associated wi th laboratory investigations were not included in you r[ Cb><4p eviati on trending. B. Your SOP-0922 v. 18 provides for cance ll ation of devia ti ons, wi th assessment and documentation of justification by your Quality Unit (QU). From 01 Apr 2023 (47) deviations were cancelled. For exampl e: i..
Observation 6 — Laboratory controls do not include the establishment of scientifically sound and appropriate
Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure that components and in-process materials conform to appropriate standards of identit y, strength, quality, and purity. Specifically, (bY{4l . A. Duplicates within 1S.enesJ.Lct.er.e11c.ELContrQI, or test samples) are removed from potency data analysis for Cb><~when exceed in g the system suitabi li ty criteria for percent coe ,,,..1c ,e ... o vana,..1o_ w 1t...- t - _un - -nt_ ..,...___ _ n..,.,.....,.-,- "" o-u...so _ ...., scientific justification . ~ ~ -- SEE REVE'RSE OF TH/$ PAG E' EMPI.O"'EE(S)NAi\AF ANO TITLE: f Pnntor Typ,} DA.TE ISSUEO Ekaterina A ll e n, Ph D, Pha rmaceutical Sc ientist Leiyu n Boone, Ph D, Lead Biologist Ka th ryn Ki ng , PhD, Biolog ist Ju ly 4, 2025 Hyung -yu l Lee, Ph.D. Pha r maceutical Scienti st Della Shon , PhD, Ph arm ace uti cal Scientist Zhong Li, Ph.D., Senior Re gulatory Sp ec1a.
Observation 7 — Your firm's documentation practices are deficient
Your firm's documentation practices are deficient. Specifically, A. During batch record review, I (LB) noted that an unexecuted manufacturing step was sign~d Fu'· performed b_yh oqerator and verified by second person as having been observed (Step r (6J(41>f (bH4 A lack of good documentation practices is also evidenced by at least fnirty-five ""t""J"""o.,.) """d'""e..,..v'""1a""'t--,o--n_s_r_e.,...1a..,..ted to incomplete documentation and missing second person verification, dating from Sep 2023 (major DEV-003274) to Jun 2025 (e .g., DEV-004933 and Ql-000337). Your firm failed to implement an adequate and effective CAPA to address the recurri ng poor doc umentation practices. B. The filter integrity testing records for High-Efficiency Partk u.lateA,ir (HEPA) fil ters installed in the classified manufacturing areas and those installed in the (b)(4Jfilling Line are deficient in that they do not include complete records of the testing data. pec1tica!!y, the measured leakage (penetration) va lue(s) for each test is (are) not documented to ensure an appropriate investigation in the event of an HEPA.
Observation 8 — Your firm failed to exercise appropriate controls to protect the electronic data
Your firm failed to exercise appropriate controls to protect the electronic data acquisition and process control systems used for OS and DP manufacturing and testing. Specifically, A. Unique login identifications for each user have not been establish ed for compur dz.ed..svste~)J For example, Tw:...s.taff...us.e~rfll shared u~ername and. pas~swnrd.Ja.Joa.l!J1o...a.l.aotoo l&>r<i access the ;ci ata acquIs1tron s~tem. fo of critical process equipment, including I (b)l4l alidatlon. 8 . c:m'..s....'ci/J~lectronic data review process is deficient. For example, audit trails enabled in the ala acquisiti on systems are not reviewed for each data set during the r----(bT<4t Cb><4!review processes. In addition, during data review on ly final printouts of the measured resuIcs are reviewed and they are not verified against the original electronic records. 4 C. D uring the power outage in January 2024, the~ n l ruBio DeltaV system was severely impacted when the DeltaV Professional PLUS server cou no be restarted and required rebuilding with database restoration. A revalidation of the computerized.
Observation 9 — Your quality unit does not fully exercise its responsibilities regarding service contractor
Your quality unit does not fully exercise its responsibilities regarding service contractor qualification. Specifically, A. Your quality unit has not conducted on-site GMP audits of all contractor service providers who perform critical qualification and validati on activities at your DS and DP manufacturing facility. For example, no audits have been conducted of the following providers: i. I (b)l1provider of qualification activities for the HVAC system (including HEPA filters), Unidirectional Air Flow (LAF) units, and Microbiological Safety Cabinets. 4 ii . I lbJ( ~provider of validator test systems for l {6ff, S EE REVERSE OF THIS PAGE EMPLOVE"E jSI SIGNAT•JRE .. ~ b o,;J EMP_OYEE(S) NAME ANO TITLE {Prll'lt ri t Type) DATE I SSIJ EO Eka tefln a Allen, Ph D, Phar ma ce ut ical Sci entist lei yun Boon e, PhD, Lead Bio logi st Ka th ryn King, PhD, 8i olog i$1 July 4, 2025 Hyung •vul Lee. Ph .D, Pharmaceut ical Sc ient is t Della.
Observation 10 — Materials management is deficient
Materials management is deficient. Specifically, A. Management of raw materials is inadequate. Not a ll raw materials are tested for idr t.itYJ:lyJh.eli r • to release for use. Based on the lists provided dur in g this inspection, a total o Cb><4 aw materials are released solely based on certificate of analysis (CoA). ~ (tif(4) B. There is a l a~k of documentat io n for disposal of cr,0 ~Y?4bed~~ Cb><4~ ot ! Cb)<j which was used in the producti on o I atch as subsequen tl y determined to be contaminated based on DEV-O0v.. 1 ::,. 1 ne mm s1a1ea that the contaminateC CliJ(4};as discarded; however, no supporting documentation could be located to verify the fi na l disposal of this material. C. DS was shipped in a container clo su re not va li dated for the intended use, as evidenced by damage to OS bags fo ll owing sh ipment to a CM 0; CbTT4hh ese shipments.
Alvotech Hf’s FDA history
Argus HQ has recorded 1 total FDA action tied to Alvotech Hf: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- Does this Form 483 mean Alvotech Hf 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.
- What happens after a Form 483 is issued?
- The firm typically has 15 business days to submit a written response describing planned corrections. FDA reviews that response, and unresolved or serious findings can lead to a Warning Letter, import alert, or other enforcement action, though many 483s are resolved without further FDA action.
- Has Alvotech Hf had other FDA inspection citations?
- This is the only FDA action Argus HQ has on file for Alvotech Hf so far. Argus ingests new FDA records daily.
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3013702557.
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Related enforcement actions
Full FDA history for Alvotech HfCompiled 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 Inspects Alvotech Hf: Form 483 with 10 Citations (July 4, 2025). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-alvotech-hf-2025-07-04-3013702557
"FDA Inspects Alvotech Hf: Form 483 with 10 Citations (July 4, 2025)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-alvotech-hf-2025-07-04-3013702557.
Argus HQ Research. "FDA Inspects Alvotech Hf: Form 483 with 10 Citations (July 4, 2025)." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-alvotech-hf-2025-07-04-3013702557.
@misc{argushq_argushq_ai_483_fda_483_alvotech_hf_2025_07_04_3013702557_2025,
title = {FDA Inspects Alvotech Hf: Form 483 with 10 Citations (July 4, 2025)},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-alvotech-hf-2025-07-04-3013702557},
note = {Accessed: July 15, 2026}
}