Drug factory · FDA FEI 3006518511

Precision Nuclear of Virginia, LLC

1634 Midland Rd, Salem, VA, United States

Problems found, fixed voluntarily at FDA's last inspection, Oct 17, 2025.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

3 drug inspections on record since 2013: 0 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Ammonia N-13	Makes it	Precision Nuclear LLC	52768-100
Fludeoxyglucose F-18	Makes it	Precision Nuclear LLC	52768-001
Fluoride Ion F-18	Makes it	Precision Nuclear LLC	52768-125
Piflufolastat F-18	Makes it	Progenics Pharmaceuticals, Inc.	71258-022

Ended	Result	Program	Problems noted
Oct 17, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	2
Nov 19, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	3
Feb 27, 2013	Problems found, fixed voluntarily	Drug Quality Assurance	—

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Written QA procedures established, followed 21 CFR 212.20(e)
You did not follow written quality assurance procedures.
Production area & equipment checks 21 CFR 212.50(d)
Your equipment in the production area was not checked to ensure cleanliness and suitability immediately before use.

Written QA procedures established, followed 21 CFR 212.20(e)
You did not establish and follow written quality assurance procedures.
Content of written procedures 21 CFR 212.40(a)
You did not follow appropriate written procedures that describe the handling of components .
Production area & equipment checks 21 CFR 212.50(d)
Your production area and equipment in the production area was not checked to ensure cleanliness and suitability immediately before use.

Registered with FDA for: positron emission tomography drug production.