Production Systems, Inc
Form 483 issued March 12, 2026 · Shoreview, Minnesota
- Inspection
- Mar 11 – Mar 12, 2026
- Investigator
- Alicia U. Jacobo
- Observations
- 1
- Pages
- 4
- FEI number
- 2182799
In short: On March 12, 2026, FDA issued a Form 483 with 1 observation to Production Systems, Inc in Shoreview, Minnesota (FEI 2182799) after an inspection that ran Mar 11 – Mar 12, 2026. The investigator was Alicia U. Jacobo. The most-cited regulation is 21 CFR 7.1 (scope).
What FDA observed
Preview: the opening words of each observation- 01ISO 13485:2016 Clause 7.1
One or more processes for risk management in product realization…
This inspection in context
Alicia U. Jacobo
4 documents · 2024–2026
Cites 803.17 (what are the requirements for developing, maintaining, and implementing written mdr procedures that apply to me?) more than any other section. Most of their documents are for sites in Minnesota.
The firmProduction Systems, Inc history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at Production Systems, Inc?
FDA listed 1 observation on this Form 483. The most-cited regulation is 21 CFR 7.1 (scope). The opening words of each observation are shown on this page.
Who inspected Production Systems, Inc?
Alicia U. Jacobo is named on this Form 483, for the inspection of Mar 11 – Mar 12, 2026. Each investigator has a profile showing what they cite most.
When was Production Systems, Inc inspected by FDA?
The inspection ran Mar 11 – Mar 12, 2026, and the Form 483 is dated March 12, 2026.
How do I get the full Form 483 for Production Systems, 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.