Key facts
| Firm | Excel Vision |
|---|---|
| FEI / inspection ID | 3007058211 |
| Inspection end date | January 22, 2026 |
| Citation count | 11 |
Citations explained
Observation 1 — There is a fai lure to thoroughly review any unexpl ained discrepancy
There is a fai lure to thoroughly review any unexpl ained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or no t the batch ha s been already distiibuted. 1. Failing sterility tests occU1Ted when returned complaint samples of~)(4> !from the US market were tested. The sterility tests evaluated the remaining liquid ins ide sample s retlllned for reports of visual contamination including mol d, black specks, and discoloration on the ~><4> I The ~_c42 J container clo sure system is designed with a'~c4 I to protect the product remaining ins ide the bottle during use. Without identifying any deficiencies m the Cb> c4> I the sterility failures were attributed to inadequate handling by customers. Inve stigations were not timely. They were clo sed with no action to address the product on the market or extend the inve stigation to other batches of this product and other products made.
Observation 2 — Aseptic proce ss ing ai·eas are deficient in that floor s, walls
Aseptic proce ss ing ai·eas are deficient in that floor s, walls and ceilings ai·e no t smooth and/or hard swfaces that ai·e easi ly cleanabl e. 4 CbH4> Jand )(4) Jai·e used in the constrnction of the 1 <bX >----, \Uf\_,,J ~ Iaseptic manufacturmg ai·eas m builclin~ The(b><4> Remediation before project swnmaiy documentb 4 ____J i denti fies this mate1ial ha s a nsk of acce erated deterioration of swfaces in contact with moisture and a:isinfectants, an inability to ensure complete decontaminati on, and a growing problem of maintaining sterile conditions in preparation areas. The document identifies the~> c41 ] mate1ial is not wate1proof. It is located in ai·eas that have been subject to water incursi ons from ramwater or utility leaks and 6 rsistent mold recoverie s. No speci fic remediation plan to fully replace the material throughout the r < ><4> ----i <bR4> 7 manufacturing ai·ea h as been established as commercial manufacturing continues using these areas..
Observation 3 — Procedures designed to prevent microbiological contamination of dmg products purp01ting to be
Procedures designed to prevent microbiological contamination of dmg products purp01ting to be sterile did not include adequate validation of the aseptic process. Inadequate smoke studie s is a repeat observation from the May 2025 Warning Letter. 1. For r <bR4r7 asep tic fi lling line lbR4> smoke studies were approved by the Quali ty Department that showed first air was dismpted above sterile surfaces and sterile components during interventions, such as: a. During installation of the r-----<bR4>~ the operator's hands dismpt the airflow to the exposed r-<bR4>-----i_ appeared to be turbulent and flowing upward during b. The airflow in the area around the'ct,><4>
Observation 4 — Procedures designed to prevent microbiological contamination of dmg products purp01ting to be
Procedures designed to prevent microbiological contamination of dmg products purp01ting to be sterile are not established. SEE REVERSE OF THIS PAGE
Observation 5 — Aseptic proce ss ing areas are deficient regarding the system for cleaning
Aseptic proce ss ing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic condi tions. 1. Equipment surfaces that directly contact ste1iletb) (4) ~> <4> I equipment in cluding the [ packa~g are not ste1ilized. ~ (b)(4) 4X > filling line I machme contact parts ke-1eft in place between batches and cfisinfected. Failure to steril ize c1itical equipment surfaces is a repeat obse1vation from the May 2025 warning letter. 2. During cleaning of the aseptic filling line ~bX4 >J on Janua1y 13 , 2026: (b)(~) a. The operator used a single wipe to clean the I I underneath the bowl, and bowl instead of getting a new wipe for each area as reqmred bySOP. The bowl was never rotated as re quired by the SOP to ensure all outer areas are disinfected. b. During cleaning ofthe 6H4> I, the operator failed to pull the component toward themselves to clean all areas of.
Observation 6 — Written procedures are not estab lis hed that describe the in-process controls
Written procedures are not estab lis hed that describe the in-process controls and examinations to be con ducted on app rop1iate samples of in -proce ss materials of each batch. 1. For thect,><4> I ste1il~(bH4>1products: a. There is no 100% vi sual inspection proce ss for ~! I bottles to detect vi sible particulates, container defect s, or other quality issues at coulcl affect product safety and efficacy. b. There is no de strnctive testing to detect c1itical defects in a statisti cally significant number of samples fi lled into~H4> !bottles. 2. For th~ 4> I sterilQ products, de strnctive te sting is used to b 4> I units fo r vi sual inspection: a. The vi sual inspectors were una ble to consistently detect pruticles smaller than~H4>Jmi crometers (μm). No alternative approaches were used to enhance the ability to pe1fo1m the inspection an the smaller particles were eliminated from the challen ge kit. b. The defect kit doe s.
Observation 7 — SEE REVERSE OF THIS PAGE EMPLOYEE(S) SIGNATURE Kare n A Bri ggs
SEE REVERSE OF THIS PAGE EMPLOYEE(S) SIGNATURE Kare n A Bri ggs , I n ve s ti g at o r -.... . _, J us ti n A Bo yd, I n ve s ti g at o r 8l;lrleef9/:IW!:ENA 8'0008-8 =,sr o1 -22-2':Q6 Kho a Nat h a n V Tra n , I n ve s ti g at o r X DATE ISSUED 1 /22/2026 FORM FDA ~83 ( 09/08) PAGE 15 ofl8 PAGES PREVIOUS EDmON OBSOLEJE INSPECTIONAL O BSERVATIONS -- 15 of 18 -- DEPARTMENT OF HEALTH AND H UMAN SERVICES FOOD AND DRUG ADMINISTRATION D I STRI CT ADDRESS ANO PH ONE NUMBER 1 2 4 20 Parklawn Drive, Room 2032 Rockville, MD 20857 OATE(S) OF INSPECTION 1 / 1 2/2026 - 1 /22/2026* FEJNUMBER 30070582 11 NAME AND T ITLE OF I NOMOUAL TO WHOM REPORT ISSUED Cedric Vandermeiren, General Manager F IRM NAME Exc
Observation 8 — Aseptic proce ss ing ai·eas are deficient regarding the system for monitoring
Aseptic proce ss ing ai·eas are deficient regarding the system for monitoring environmental conditi ons. There is no surface moni to1ing of Grade A surfaces in the~> c41 Imachine.
Observation 9 — App rop1iate con tro ls are not exercised over computers or related
App rop1iate con tro ls are not exercised over computers or related systems to assure that changes in master p roduction and control records or other records ai·e insti tuted only by authorized personnel. App rop1iate con trols are no t exercised over comp uters or related systems to assure that changes in master p roduction and control records or other records ai·e insti tuted only by authorized personnel. The software used to operate the ~H4> d Machine does not have indivi dua l usemame and passwords. Operators can make changes to pai·ameters like 11ling times (volume) and ~H4> I There is no audit trail to document what setting s were used and any changes made.
Observation 10 — Records ai·e not kep t fo r the main tenance and inspection
Records ai·e not kep t fo r the main tenance and inspection of equipment. SEE REVERSE OF THIS PAGE
Observation 11 — Written procedures ai·e not fo llowed for evaluations conducted at least aimually
Written procedures ai·e not fo llowed for evaluations conducted at least aimually to review records associated with a representative number of batche s, whether approved or rejected. Your furn fa il ed to conduct annual product revi ews in a timely maimer to ensure that appropri ate conective actions ai·e taken when necess aiy. XLV-PQR-RAP-0046, APR for~H4> Iremains in draft status at.the time of the inspection, approximately sev en months after the review peliod ended. The draft review covers tl batches that were di scai·ded during the review pe1iod . ~ out ofl(bH4> 2025 aimual product reviews were late or ai·e not yet completed for US products. *DATES OF INSPECTI ON l/12/2026(Mon), 1/ 13/2026(Tue), 1/l 4/2026(Wed) , l/l 5/2026(Thu), 1/16/2026(Fri), 1/19/2026(Mon), 1/20/2026(Tue), 1/21/2026(Wed), 1/ 22/2026(Thu) SEE REVERSE OF THIS PAGE
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.
Excel Vision’s FDA history
Argus HQ has recorded 2 total FDA actions tied to Excel Vision: 0 warning letters, 0 recalls, 0 approval records, and 2 Form 483 inspection citations.
Frequently asked questions
- Does this Form 483 mean Excel Vision 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 Excel Vision had other FDA inspection citations?
- Yes. Argus HQ has recorded 2 total FDA actions tied to Excel Vision, including 2 Form 483 inspection citations.
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3007058211.
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Related enforcement actions
Full FDA history for Excel VisionCompiled 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 (2026). Form 483 Record: Excel Vision, January 22, 2026 — 11 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-excel-vision-2026-01-22-3007058211
"Form 483 Record: Excel Vision, January 22, 2026 — 11 Citations." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/483/fda-483-excel-vision-2026-01-22-3007058211.
Argus HQ Research. "Form 483 Record: Excel Vision, January 22, 2026 — 11 Citations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-excel-vision-2026-01-22-3007058211.
@misc{argushq_argushq_ai_483_fda_483_excel_vision_2026_01_22_3007058211_2026,
title = {Form 483 Record: Excel Vision, January 22, 2026 — 11 Citations},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-excel-vision-2026-01-22-3007058211},
note = {Accessed: July 13, 2026}
}