Knoll LLC
Form 483 issued February 20, 2020 · Jayuya, Puerto Rico
- Inspection
- Feb 5 – Feb 20, 2020
- Investigators
- Ivis L. Negron Torres· Noreen Muniz
- Observations
- 4
- Pages
- 5
- FEI number
- 3000210838
In short: On February 20, 2020, FDA issued a Form 483 with 4 observations to Knoll LLC in Jayuya, Puerto Rico (FEI 3000210838) after an inspection that ran Feb 5 – Feb 20, 2020. The investigators were Ivis L. Negron Torres and Noreen Muniz. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment…
- 03
Laboratory records are deficient in that they do not include a complete record of all…
- 04
Determinations of conformance to appropriate written specifications for acceptance are deficient…
This inspection in context
Ivis L. Negron Torres
6 documents · 2017–2026
Cites 211.160 (general requirements) 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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Knoll LLC?
FDA listed 4 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Knoll LLC?
Ivis L. Negron Torres and Noreen Muniz are named on this Form 483, for the inspection of Feb 5 – Feb 20, 2020. Each investigator has a profile showing what they cite most.
When was Knoll LLC inspected by FDA?
The inspection ran Feb 5 – Feb 20, 2020, and the Form 483 is dated February 20, 2020.
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.