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FDA Inspection
•Noven Pharmaceuticals Inc•August 24, 2026

Noven Pharmaceuticals Inc – FDA Inspection, Aug 24, 2026

Record Details

This FDA Inspection record concerns Noven Pharmaceuticals Inc, with an inspection on August 24, 2026, issued by the Florida District Office, covering human drugs.

Company
Noven Pharmaceuticals Inc
Inspection Date
August 24, 2026
Product Type
Human Drugs
Office
Florida District Office
Person
  • Michael Z. Weigman (Investigator)
View Company Profile

ID · b507cc55-690a-4ba4-a7d4-56ddea6c81e7

Inspection Facts

Inspection number
1319056
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued, view the record

FDA Citations

4
  1. 21 CFR 211.194(a)(8)Second person sign off
  2. 21 CFR 211.68(b)Backup file not maintained
  3. 21 CFR 211.68(b)input/output verification
  4. 21 CFR 211.84(d)(1)Identity Testing of Each Component

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Noven Pharmaceuticals Inc

8
DateClassificationOfficeProject area
February 13, 2026Not classifiedFlorida District Office
November 17, 2021VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
January 26, 2018VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
July 10, 2015OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
September 24, 2012NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 8 other inspections on the company page
Other documents for Noven Pharmaceuticals Inc
  • FDA Inspection 1285900 - 2026-02-13
  • FDA Inspection 1156913 - 2021-11-17
  • FDA Inspection 1040075 - 2018-01-26
  • FDA Inspection 934846 - 2015-07-10
  • FDA Inspection 800319 - 2012-09-24

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