Kenvue Brands LLC
Form 483 issued September 21, 2015 · Lititz, Pennsylvania
- Inspection
- Sep 16 – Sep 21, 2015
- Investigator
- Anita R. Michael
- Observations
- 1
- Pages
- 1
- FEI number
- 2510770
In short: On September 21, 2015, FDA issued a Form 483 with 1 observation to Kenvue Brands LLC in Lititz, Pennsylvania (FEI 2510770) after an inspection that ran Sep 16 – Sep 21, 2015. The investigator was Anita R. Michael. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations of a failure of a batch or any of its components to meet any of…
This inspection in context
Anita R. Michael
18 documents · 2006–2020
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmKenvue Brands LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kenvue Brands LLC?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Kenvue Brands LLC?
Anita R. Michael is named on this Form 483, for the inspection of Sep 16 – Sep 21, 2015. Each investigator has a profile showing what they cite most.
When was Kenvue Brands LLC inspected by FDA?
The inspection ran Sep 16 – Sep 21, 2015, and the Form 483 is dated September 21, 2015.
How do I get the full Form 483 for Kenvue Brands 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.