Active Creations LLC
Form 483 issued November 2, 2021 · Edison, New Jersey
- Inspection
- Oct 20 – Nov 2, 2021
- Investigator
- Adetutu Gidado
- Observations
- 2
- Pages
- 3
- FEI number
- 3008889778
In short: On November 2, 2021, FDA issued a Form 483 with 2 observations to Active Creations LLC in Edison, New Jersey (FEI 3008889778) after an inspection that ran Oct 20 – Nov 2, 2021. The investigator was Adetutu Gidado. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68(b) (1×) · 211.67(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the…
This inspection in context
Adetutu Gidado
16 documents · 2016–2025
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New Jersey.
The firmActive Creations LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Active Creations LLC?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Active Creations LLC?
Adetutu Gidado is named on this Form 483, for the inspection of Oct 20 – Nov 2, 2021. Each investigator has a profile showing what they cite most.
When was Active Creations LLC inspected by FDA?
The inspection ran Oct 20 – Nov 2, 2021, and the Form 483 is dated November 2, 2021.
How do I get the full Form 483 for Active Creations 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.