Knoll LLC
Form 483 issued April 18, 2024 · Jayuya, Puerto Rico
- Inspection
- Apr 10 – Apr 18, 2024
- Investigator
- Libia M. Lugo
- Observations
- 2
- Pages
- 4
- FEI number
- 3000210838
In short: On April 18, 2024, FDA issued a Form 483 with 2 observations to Knoll LLC in Jayuya, Puerto Rico (FEI 3000210838) after an inspection that ran Apr 10 – Apr 18, 2024. The investigator was Libia M. Lugo. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.160(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate standards and sampling plans…
This inspection in context
Libia M. Lugo
24 documents · 2013–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmKnoll LLC history
All 2 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 Knoll LLC?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. 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 Knoll LLC?
Libia M. Lugo is named on this Form 483, for the inspection of Apr 10 – Apr 18, 2024. Each investigator has a profile showing what they cite most.
When was Knoll LLC inspected by FDA?
The inspection ran Apr 10 – Apr 18, 2024, and the Form 483 is dated April 18, 2024.
How do I get the full Form 483 for Knoll 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.