Form FDA 483 · Issued 2026-06-17
XeCare LLC — FDA Form 483 Analysis
FEI: 3017865039 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Producer of Sterile and Non Sterile Drug Products) · Lead Investigator: Elena R. Rostova
FDA Form 483 issued to XeCare LLC (FEI 3017865039) on 2026-06-17 following an inspection of its producer of sterile and non sterile drug products operations in Ohio. The report documents 3 inspection observations centered on Personnel GMP Training, Gowning & Hygienic Practices, Incoming Ingredient Identity Testing & COA Qualification.
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Observation-by-Observation 21 CFR Breakdown (3)
Observation #1 · 21 CFR 211.25(a)
Personnel GMP Training, Gowning & Hygienic Practices
FIRST-TIME OBSERVATION
Training , Education , Experience overall
Inspector Observation Language: "Employees engaged in the [manufacture] [processing] [packing] [holding] of a drug product lack the [education] [training] [experience] required to perform their assigned functions. Specifically, observed during inspection of XeCare LLC on 2026-06-17."
Plain-English Meaning: Operators performing manufacturing or QA tasks without documented GMP/SOP training, or observed gowning/hygiene deviations in production rooms.
Standard CAPA Remediation Path: Maintain role-based SOP training matrices signed prior to independent floor assignment and annual cGMP refresher assessments.
Observation #2 · 21 CFR 211.84(d)(2)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Reports of Analysis (Components)
Inspector Observation Language: "Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without [performing at least one specific identity test on each component] [establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals]. Specifically, observed during inspection of XeCare LLC on 2026-06-17."
Plain-English Meaning: Failure to perform at least one test to verify the identity of every incoming dietary ingredient or raw component before use, or relying on a supplier's Certificate of Analysis (COA) without first qualifying the supplier.
Standard CAPA Remediation Path: Establish SOP-QA-004 requiring FTIR/HPLC/organoleptic identity testing on 100% of incoming dietary ingredient lots and annual audit + 3-lot confirmatory testing before relying on any vendor COA.
Observation #3 · 21 CFR 211.58
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Buildings not maintained in good state of repair
Inspector Observation Language: "Buildings used in the [manufacturing] [processing] [packing] [holding] of a drug product are not maintained in a good state of repair. Specifically, observed during inspection of XeCare LLC on 2026-06-17."
Plain-English Meaning: Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
Standard CAPA Remediation Path: Enforce unique user credentials, immutable audit trails on analytical instruments, controlled form issuance numbers, and 2-year post-expiration record retention.