Turnco Tool & Instrument, Inc
Form 483 issued February 11, 2026 · Georgetown, Texas
- Inspection
- Feb 9 – Feb 11, 2026
- Investigator
- Elizabeth A. Krolczyk
- Observations
- 2
- Pages
- 4
- FEI number
- 3009241418
In short: On February 11, 2026, FDA issued a Form 483 with 2 observations to Turnco Tool & Instrument, Inc in Georgetown, Texas (FEI 3009241418) after an inspection that ran Feb 9 – Feb 11, 2026. The investigator was Elizabeth A. Krolczyk. 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…
- 02ISO 13485:2016 Clause 7.5.1
Production controls do not include documentation of procedures and methods for…
This inspection in context
Elizabeth A. Krolczyk
6 documents · 2024–2026
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in Texas.
The firmTurnco Tool & Instrument, Inc history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at Turnco Tool & Instrument, Inc?
FDA listed 2 observations 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 Turnco Tool & Instrument, Inc?
Elizabeth A. Krolczyk is named on this Form 483, for the inspection of Feb 9 – Feb 11, 2026. Each investigator has a profile showing what they cite most.
When was Turnco Tool & Instrument, Inc inspected by FDA?
The inspection ran Feb 9 – Feb 11, 2026, and the Form 483 is dated February 11, 2026.
How do I get the full Form 483 for Turnco Tool & Instrument, 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.