Key facts
| Firm | Excel Vision |
|---|---|
| FEI / inspection ID | 3007058211 |
| Inspection end date | November 19, 2024 |
| Citation count | 5 |
Citations explained
Observation 1 — Written record s of investigations into unexplai ned discrepancies do not always
Written record s of investigations into unexplai ned discrepancies do not always include th e conclusions a nd follow-up. Specifically, From 01 /2023 to date, about 120 complaints from the U.S. market were received regarding mold, black specks, and discoloration being observed on thel CbTOO,t: aps, and insi~e ofth CbTc4 __<!rug products manufactured in Buildin~ Cb>14!fi1I lines1 Cb)<~ mold complaints impact (b} ;! (b)14~ . (b)14 ~p. s. products nd mvolved different batches. Your firm's complaint investigations are inadequate to assure product quality and patient safety. Specifically, A. We reviewed about 40 investigations, all concluded that the mold is probably due to improper use and/or storage of the product bottle by the patients. No non-conformity could be identified within Excelvision. However, you do not have documented evidence to support that improper handling by th e end-users being the root cause or probable root cause. No patients or end-users were contacted or interviewed indicating improper use of the products. B. Investigations.
Observation 2 — 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 did n ot include adequate validation of the aseptic process. Specifically, Smoke Studies: S EE REVE RS E OF THI S PAGE El,l/>L.OYEE($1 SIGMA TURE ENPLOYEE(S) NAME )NO Trtl.E (PIIOtO' T)'J)t} <-6~ Eileen A. Liu, Inves ti gator (Lead) An geli ca M. Hern andez, Investigator MJG- DATE ISSUED 11/19/2024 FORM FDA ¢l (09/08) PRJMOVS il:XXTION 08$0U11i': tNSPECTIONAL OBSERVATIONS PAGE 2 OF 6 PAGES
Observation 3 — Aseptic processing areas are deficient regarding the system for cleaning and disinfecting
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. Spe cifically, J (6)(4 . A. an <\_ are being used to clean th e' (b)141Gr.ade..e. ctHljng machine 1 ~ces. However, you do not have a validation study to show that theI l is effective against mold species. B. Workinstruction (WI)! (b)1 4l oes not contain sufficient details on how to clean 4 the (b)( filling machine surfaces. For example, the bottle bowl comes into contact with sterile bottles used to fill the sterile! (b,<, drug products. r o ;ve_ye.r the only inJ~truction written in the above WI is to "Clean the inside of the bottle bowl". (bH ; ctoes not have adequate cleaning details to prevent microbial contaminkhon orclrug products purporting to be sterile.
Observation 4 — Aseptic processing areas are deficient regarding systems for maintaining any equipment used
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the a septic conditions. Specifically, SEE REVERSE OF THIS PAGE ENPlO YEE(S} S/GIIATIJP.E EMPt.OYEE(S} NAME AND 71TLE (Prtltc, Typ,) 6 1 ~ Eileen A. Liu, Investiga tor (Lead) Angelica M. Hernandez, Investiga to r A4-,0- CATE ISS\IEO 11/ 1 9/ 2024 FOI\M FDA ◄S) (09103) f'REVlOV$ED1TIONQNOC.tTS INSPEcnONAL OBSERVATIONS PACE S O~ & PAGES
Observation 5 — Laboratory records do not include the initials or signature of a second
Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness, compliance with established standards. Specifically, On 11/13/2024, I (EL) reviewed the! <6TT 4 ~ 1l lines Grade D ~gowning room) viable (bT<4!air and surface monitoring records.[ (b,c 4 p ut of the total! (b) ro: !ates reviewed showed maccurate colony enumerations. The discrepancy was confirmed by the QC Microbiology supervisor. Your environmental monitoring data is not subject to second-person review to make certain that all test results and associated information are appropriately reported. EMPI.OYEE(S) S/GNATIJFIE EMPWYEE(S) NI.ME ANO TIT!£(Print er Typ,) DATE ISSI.ED ~~ 11/19/2024 SEE Eileen A. Liu, Inves tigator (Lead) REVERSE OF ~ THIS PAGE An gelica M. Hernan dez, Investigator FORM FDA ◄ S3 ( 09108) MB\ltOUSmff'ION OBSOLCrE INSPJi!CTIONAL OBSERVATIONS PAGE 6 OF 6 PAGES
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
- 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.
- 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.
See if this 483 escalates to a warning letter — before your auditor asks.
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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 (2024). FDA Form 483 — Excel Vision (November 19, 2024) — 5 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-excel-vision-2024-11-19-3007058211
"FDA Form 483 — Excel Vision (November 19, 2024) — 5 Citations." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/483/fda-483-excel-vision-2024-11-19-3007058211.
Argus HQ Research. "FDA Form 483 — Excel Vision (November 19, 2024) — 5 Citations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-excel-vision-2024-11-19-3007058211.
@misc{argushq_argushq_ai_483_fda_483_excel_vision_2024_11_19_3007058211_2024,
title = {FDA Form 483 — Excel Vision (November 19, 2024) — 5 Citations},
author = {{Argus HQ Research}},
year = {2024},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-excel-vision-2024-11-19-3007058211},
note = {Accessed: July 13, 2026}
}