Knoll LLC
Form 483 issued October 23, 2015 · Jayuya, Puerto Rico
- Inspection
- Oct 7, 2015
- Investigator
- Jose Velez
- Observations
- 3
- Pages
- 4
- FEI number
- 2650166
In short: On October 23, 2015, FDA issued a Form 483 with 3 observations to Knoll LLC in Jayuya, Puerto Rico (FEI 2650166) after an inspection that ran Oct 7, 2015. The investigator was Jose Velez. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
2 of 3 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (2×) · 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not fully followed. There is…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in…
This inspection in context
Jose Velez
24 documents · 2014–2026
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
The site's inspection history, in date order.
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 3 observations 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 Knoll LLC?
Jose Velez is named on this Form 483, for the inspection of Oct 7, 2015. Each investigator has a profile showing what they cite most.
When was Knoll LLC inspected by FDA?
The inspection ran Oct 7, 2015, and the Form 483 is dated October 23, 2015.
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.