Noven Pharmaceuticals, Inc.
Form 483 issued November 17, 2021 · Miami, Florida
- Inspection
- Nov 1 – Nov 17, 2021
- Investigator
- Lillian M. Colon-Mcknight
- Observations
- 4
- Pages
- 4
- FEI number
- 1000222037
In short: On November 17, 2021, FDA issued a Form 483 with 4 observations to Noven Pharmaceuticals, Inc. in Miami, Florida (FEI 1000222037) after an inspection that ran Nov 1 – Nov 17, 2021. The investigator was Lillian M. Colon-Mcknight. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Facilities & equipment and quality system account for 4 of 4 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment for adequate control over dust, humidity and temperature is not provided when appropriate for the…
- 02
Written procedures for sanitation…
- 03
Investigations of an unexplained discrepancy did not extend to other batches of the same drug product…
- 04
There is a failure to thoroughly review whether or not the batch…
This inspection in context
Lillian M. Colon-Mcknight
3 documents · 2021–2022
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Florida.
The firmNoven Pharmaceuticals, Inc. 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 Noven Pharmaceuticals, Inc.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and 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 Noven Pharmaceuticals, Inc.?
Lillian M. Colon-Mcknight is named on this Form 483, for the inspection of Nov 1 – Nov 17, 2021. Each investigator has a profile showing what they cite most.
When was Noven Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Nov 1 – Nov 17, 2021, and the Form 483 is dated November 17, 2021.
How do I get the full Form 483 for Noven Pharmaceuticals, Inc.?
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.