Life Science Nutritionals Inc.
Form 483 issued April 20, 2023
- Inspection
- Apr 17 – Apr 20, 2023
- Investigator
- Brandon M. Kurjanowicz
- Observations
- 2
- Pages
- 3
- FEI number
- 3013030928
In short: On April 20, 2023, FDA issued a Form 483 with 2 observations to Life Science Nutritionals Inc. (FEI 3013030928) after an inspection that ran Apr 17 – Apr 20, 2023. The investigator was Brandon M. Kurjanowicz. Most observations concern dietary supplement CGMP; the most-cited regulation is 21 CFR 111.210 (what must the master manufacturing record include?).
At a glance
2 of 2 observations on this 483 concern dietary supplement cgmp.
Most cited: 21 CFR 111.210 (1×) · 111.260 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The written instructions in your master manufacturing record did not include procedures for sampling and a…
- 02
Your batch production records did not include the date and time of the maintenance, cleaning, and…
This inspection in context
Brandon M. Kurjanowicz
1 document · 2023
Cites 111.210 (what must the master manufacturing record include?) more than any other section.
The firmLife Science Nutritionals Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 111.210
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Life Science Nutritionals Inc.?
FDA listed 2 observations on this Form 483, mostly about dietary supplement CGMP. The most-cited regulation is 21 CFR 111.210 (what must the master manufacturing record include?). The opening words of each observation are shown on this page.
Who inspected Life Science Nutritionals Inc.?
Brandon M. Kurjanowicz is named on this Form 483, for the inspection of Apr 17 – Apr 20, 2023. Each investigator has a profile showing what they cite most.
When was Life Science Nutritionals Inc. inspected by FDA?
The inspection ran Apr 17 – Apr 20, 2023, and the Form 483 is dated April 20, 2023.
How do I get the full Form 483 for Life Science Nutritionals 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.