Drug factory · FDA FEI 3007939497

Hot Shots Nm, LLC

2017 E Kimberly Rd, Davenport, IA, United States

Problems found, fixed voluntarily at FDA's last inspection, Aug 9, 2019.

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

2 drug inspections on record since 2013: 0 with no problems, 2 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
Flurpiridaz F-18	Makes it	GE Healthcare Inc.	0407-8787
Piflufolastat F-18	Makes it	Progenics Pharmaceuticals, Inc.	71258-022

Ended	Result	Program	Problems noted
Aug 9, 2019	Problems found, fixed voluntarily	Drug Quality Assurance	3
Oct 31, 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.

Determination need for investigation 21 CFR 212.20(d)
When errors occurred or a production batch or any component of the batch, failed to meet specifications, you did not determine the need for an investigation, conduct an investigation and take appropriate corrective actions when necessary.
Contact surfaces 21 CFR 212.30(c)
Your equipment is not constructed and maintained so that surfaces that contact components, in-process materials and PET drugs are not reactive, additive, or absorptive so as to alter the quality of the PET drugs.
Production area & equipment checks 21 CFR 212.50(d)
Your production area was not checked to ensure cleanliness and suitability immediately before use.

Registered with FDA for: positron emission tomography drug production.