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 XeCare LLC had other FDA inspection citations?

This is the only FDA action Argus HQ has on file for XeCare LLC so far. Argus ingests new FDA records daily.

What is the FEI / inspection ID for this Form 483?

FEI / inspection ID: 3017865039.

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.

FDA Inspects XeCare LLC: Form 483 with 3 Citations (June 17, 2026)

Key facts

Firm	XeCare LLC
FEI / inspection ID	3017865039
Inspection end date	June 17, 2026
Citation count	3

The short version: FDA inspected XeCare LLC in Ohio and issued a Form 483 listing 3 inspectional observations following an inspection that concluded 2026-06-17. FDA records classify XeCare LLC as a producer of sterile and non sterile drug products. A Form 483 documents an investigator's findings at the close of an inspection under the Federal Food, Drug, and Cosmetic Act; it is not a final agency compliance determination. The observations on this page are drawn directly from the FDA-issued Form 483 record. 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 — Hazardous drugs were produced without providing adequate containment, segregation, and/or

Hazardous drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utens il s, and/or personnel to prevent cross-contamination. Specifically, 1) Your film routinely produces hazardous drug products on shared tablet press equipment without employing a deactivating agent as part of the cleaning process between batches, relying solely on ~b) (4 ) -1 From 6/3/2026 through 6/9/2026, your firm produced the following 1111 hazardous drug products sequentially on tablet press NP4-2405 with only ~b) (4 ) I cleaning perfotmed between each product: a. Tadalafil 8.5mg + Enclomiphene citrate 12.5mg tablets lots DFJRJFLEQPRS and QHKTRRHEKQFE b. Tadalafil 8.5mg + Finasteride 1.2mg + Minoxidil 3mg + Biotin 2.5mg + Vit B12 !mg + Vit 03 0.05mg + L-Theanine 50m g Table ts lots IKTI DKQP CGUT and TIGISITHFHGD C. Naltrexone HCL 14mg + Topiramate 44mg Vitamin Bl2 1mg Tablets lots UFISFTCFFTPS and DLCQHEGLUTQE 2) Your firm routinely performs ha zardous drug powder weighing and sifting operations in Room I 04, your designated hazardous weighing room, under conditions that do not consistently meet the req uired negative air pressure specifications. Review of

Observation 2 — Materials were exposed to lower than ISO 5 quality air. Specifically, On 5/ 16/2026,

Materials were exposed to lower than ISO 5 quality air. Specifically, On 5/ 16/2026, during production of Semaglutide 5mg/2mL Solution for Injection, lot CERKTLEQQQIJ, we observed, via video review, the following poor transfers of material into the !SO S hood resulting in the material being exposed to the IS0-7 environment. EMPLOYEE(S) SIGNATURE OATE I SSUEO SEE REVERSE Logan T Williams , Investigator 6/17/2026 OF THIS PAGE Kara J Wright , Investigator X INSPECTIONAL OBSERVATI ONS PA GE !ofl rAGES FORM fDA ~8J (0 9/0N) PRl:V!Ol'S l;0ITf()N ODSO Ll:i\: I -- 2 of 4 -- Ka ta JWt~ ftwOSllg.,. lo, S'9n«1 8y, i00"4334 Ut X Oi't Sign•d. 06- 17 -2026 13 .C9 26 DEPARTM ENT OF' HEA LTH AND HU MAN SE RV IC ES fOOU AND DRUG 1\ DM IN ISIRAT ION DISTRICT ADDRESS ANO PHONE NUMBER DATE(S)OF INSPECIION 550 Main Street , Ste 4-930 6/8/2026-6/17/2026* Cincinnati , OH 45202 FEJNUMBER 3017865039 (513) 322-0700 E'a x: (513 ) 679-2772 NA M€ ANO 1 1TLE OF IKOIVU)UAl TO IA~OM REPORT ISSU ED Andrew T . Bruggeman I Director , 503A Phar ma cist i n Charge FIRM NAME STREET ADDRESS XeCare LLC 9750 In nova tion Campus Way CITY. STATE. ZIP CODE. COUNTRY TIPE ESTAll.lSHl<ENT INSPECTED New Albany , OH 43054 - 7708

Observation 3 — Use of ingredients not intended for pharmaceutical use in non-sterile drug production.

Use of ingredients not intended for pharmaceutical use in non-sterile drug production. Specifica lly, Your finn makes Minoxidil 1.5mg + Biotin 2.5mg chewable gummy products using {b) (4) ~ water that has not been tested. This water is used in your firm's formulation of the gwnmy product. Untested 4 t b>< > water was used in the production of Minoxidil 1.5mg + Biotin 2.5mg chewable gummy lot UGDFEUSJHFGJ. *DATES OF INSP ECT ION 6/08/2026(Mon), 6/09/2026(Tue), 6/10/2026(Wed), 6/l 1/2026(Thu), 6/ l 2/2026(Fri), 6/ 15/2026(Mon ), 6/ l 6/2026(Tue), 6/ l 7/2026(Wed) SEE REVERSE OF THIS PAGE E"'PLOVEE(SJ S!Gs<AT~E Logan T Williams , Investigator Kara J Wright, In vestigato r t.ogan r 'IM•ms DATE ISSUED 6/17/2026 lnw\!lf• IM s,,....,., k)O)ffiM~ 0.1tS,.,.,.. Ol,112028 Uotl-' X PAGE 3of3 PAGES FORM FDA ~SJ (09108) p,u,·1Dl'S EDITI ON 08SOLETI! INSPECT IONAL OBSERVATIONS -- 3 of 4 -- The observations of objectionable conditions and practices listed on the front of this form are reported: 1. Pursuant to Section 704(b) of the Federal Food , Drug and Cosmetic Act, or 2. To assist firms inspected in complying with the Acts and regulations enforced by the Food and Drug Admin istration. Section 70

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.

XeCare LLC’s FDA history

Argus HQ has recorded 1 total FDA action tied to XeCare LLC: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.

Frequently asked questions

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 XeCare LLC had other FDA inspection citations?: This is the only FDA action Argus HQ has on file for XeCare LLC so far. Argus ingests new FDA records daily.
What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 3017865039.
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.

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Full FDA history for XeCare LLC

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.

APA

Argus HQ Research (2026). FDA Inspects XeCare LLC: Form 483 with 3 Citations (June 17, 2026). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/483/xecare-3017865039-2026-06-17

MLA

"FDA Inspects XeCare LLC: Form 483 with 3 Citations (June 17, 2026)." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/483/xecare-3017865039-2026-06-17.

Chicago

Argus HQ Research. "FDA Inspects XeCare LLC: Form 483 with 3 Citations (June 17, 2026)." Digital Empire Holdings LLC. Accessed September 11, 2026. https://argushq.ai/483/xecare-3017865039-2026-06-17.

BibTeX

@misc{argushq_argushq_ai_483_xecare_3017865039_2026_06_17_2026,
  title = {FDA Inspects XeCare LLC: Form 483 with 3 Citations (June 17, 2026)},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/483/xecare-3017865039-2026-06-17},
  note = {Accessed: September 11, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗