PETNET Solutions, Inc.
Form 483 issued September 2, 2025 · North Wales, Pennsylvania
- Inspection
- Aug 26 – Sep 2, 2025
- Investigator
- Anastasia M. Shields
- Observations
- 1
- Pages
- 2
- FEI number
- 3007684134
In short: On September 2, 2025, FDA issued a Form 483 with 1 observation to PETNET Solutions, Inc. in North Wales, Pennsylvania (FEI 3007684134) after an inspection that ran Aug 26 – Sep 2, 2025. The investigator was Anastasia M. Shields. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 212.30 (what requirements must my facilities and equipment meet?).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 212.30(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Your facilities are not adequate to ensure the prevention of contamination of equipment or product by…
This inspection in context
Anastasia M. Shields
45 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmPETNET Solutions, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 212.30(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, mostly about facilities & equipment. The most-cited regulation is 21 CFR 212.30 (what requirements must my facilities and equipment meet?). The opening words of each observation are shown on this page.
Who inspected PETNET Solutions, Inc.?
Anastasia M. Shields is named on this Form 483, for the inspection of Aug 26 – Sep 2, 2025. Each investigator has a profile showing what they cite most.
When was PETNET Solutions, Inc. inspected by FDA?
The inspection ran Aug 26 – Sep 2, 2025, and the Form 483 is dated September 2, 2025.
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.