JKR Pharmacy Ventures, LLC dba Lane's Veterinary Pharmacy

Form 483 issued December 19, 2025 · Lexington, Kentucky

Inspection: Dec 3 – Dec 19, 2025
Investigator: Lisa R. Hilliard
Observations: 11
Pages: 12
FEI number: 3033262505

In short: On December 19, 2025, FDA issued a Form 483 with 11 observations to JKR Pharmacy Ventures, LLC dba Lane's Veterinary Pharmacy in Lexington, Kentucky (FEI 3033262505) after an inspection that ran Dec 3 – Dec 19, 2025. The investigator was Lisa R. Hilliard. Most observations concern production and materials; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).

At a glance

Production and materials account for 7 of 11 observations.

Production4

Materials3

Laboratory controls2

Facilities & equipment1

Other1

Most cited: 21 CFR 211.113 (3×) · 211.84 (2×)

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

01
21 CFR 211.42
Aseptic processing areas are deficient regarding the system…
02
21 CFR 211.113
Procedures designed to prevent microbiological contamination of ding products purporting to be sterile did not include…
03
21 CFR 211.113
Procedures designed to prevent microbiological contamination of ding products purporting to be sterile are not…
04
21 CFR 211.28
Clothing of personnel engaged in the manufacturing, processing, packing and holding of drug products is not…

7 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

The investigator

Lisa R. Hilliard

15 documents · 2021–2026

Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Ohio.

The firm

JKR Pharmacy Ventures, LLC dba Lane's Veterinary Pharmacy history

All 2 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.113

See how FDA wrote the same problem up elsewhere.

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Form 483 from this inspectionDec 3, 2025$99

JKR Pharmacy Ventures, LLC dba Lane's Veterinary Pharmacy site file

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Questions about this 483

What did FDA find at JKR Pharmacy Ventures, LLC dba Lane's Veterinary Pharmacy?

FDA listed 11 observations on this Form 483, mostly about production, materials and laboratory controls. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.

Who inspected JKR Pharmacy Ventures, LLC dba Lane's Veterinary Pharmacy?

Lisa R. Hilliard is named on this Form 483, for the inspection of Dec 3 – Dec 19, 2025. Each investigator has a profile showing what they cite most.

When was JKR Pharmacy Ventures, LLC dba Lane's Veterinary Pharmacy inspected by FDA?

The inspection ran Dec 3 – Dec 19, 2025, and the Form 483 is dated December 19, 2025.

How do I get the full Form 483 for JKR Pharmacy Ventures, LLC dba Lane's Veterinary Pharmacy?

Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.