PETNET Solutions Inc
Form 483 issued March 19, 2026 · Alabama
- Inspection
- Mar 17 – Mar 19, 2026
- Investigators
- Lillian S. Wu· Youkeun Kim
- Observations
- 1
- Pages
- 3
- FEI number
- 3008769593
In short: On March 19, 2026, FDA issued a Form 483 with 1 observation to PETNET Solutions Inc in Alabama (FEI 3008769593) after an inspection that ran Mar 17 – Mar 19, 2026. The investigators were Lillian S. Wu and Youkeun Kim. The most-cited regulation is 21 CFR 212.60 (what requirements apply to the laboratories where I test components, in-process materials, and finished PET drug products?).
What FDA observed
Preview: the opening words of each observation- 01
Each laboratory used to conduct testing of finished PET drug products does not follow written procedures…
This inspection in context
Lillian S. Wu
11 documents · 2022–2026
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) more than any other section. Most of their documents are for sites in California.
The firmPETNET Solutions Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 212.60(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PETNET Solutions Inc?
FDA listed 1 observation on this Form 483. The most-cited regulation is 21 CFR 212.60 (what requirements apply to the laboratories where I test components, in-process materials, and finished PET drug products?). The opening words of each observation are shown on this page.
Who inspected PETNET Solutions Inc?
Lillian S. Wu and Youkeun Kim are named on this Form 483, for the inspection of Mar 17 – Mar 19, 2026. Each investigator has a profile showing what they cite most.
When was PETNET Solutions Inc inspected by FDA?
The inspection ran Mar 17 – Mar 19, 2026, and the Form 483 is dated March 19, 2026.
How do I get the full Form 483 for PETNET Solutions Inc?
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.