Sigan America, LLC
Form 483 issued September 1, 2022 · Ottawa, Illinois
- Inspection
- Aug 30 – Sep 1, 2022
- Investigator
- Norman K. Starks
- Observations
- 2
- Pages
- 3
- FEI number
- 3008656614
In short: On September 1, 2022, FDA issued a Form 483 with 2 observations to Sigan America, LLC in Ottawa, Illinois (FEI 3008656614) after an inspection that ran Aug 30 – Sep 1, 2022. The investigator was Norman K. Starks.
What FDA observed
Preview: the opening words of each observation- 01
procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not…
- 02
procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for…
This inspection in context
Norman K. Starks
10 documents · 2018–2024
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in Illinois.
The firmSigan America, LLC history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at Sigan America, LLC?
FDA listed 2 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Sigan America, LLC?
Norman K. Starks is named on this Form 483, for the inspection of Aug 30 – Sep 1, 2022. Each investigator has a profile showing what they cite most.
When was Sigan America, LLC inspected by FDA?
The inspection ran Aug 30 – Sep 1, 2022, and the Form 483 is dated September 1, 2022.
How do I get the full Form 483 for Sigan America, LLC?
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.