Noven Pharmaceuticals, Inc.
FDA inspection history in Miami, Florida, 2016 to 2021
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2016: one warning letter; 2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One warning letter, at Miami, Florida.
- 2021One Form 483, at Miami, Florida.
Cited most
Across all Noven Pharmaceuticals observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.160General requirements1
- 21 CFR 211.46Ventilation, air filtration, air heating and cooling1
- 21 CFR 211.56Sanitation1
The complete Noven Pharmaceuticals file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Miami, Florida
One Form 483 and one warning letter · 2016 to 2021 · 4 observations
Latest: Form 483, Nov 17, 2021 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-11-17 | 483 Form 483 | Miami, Florida | 4 | $99 |
| 2016-08-05 | Warning letter Warning letter | Miami, Florida | — | $99 |
Investigators on these documents
FEI number 1000222037 · most recent document Nov 17, 2021
About Noven Pharmaceuticals, Inc.
How many FDA Form 483s has Noven Pharmaceuticals, Inc. received?
FDA Intel has 1 Form 483 on file for Noven Pharmaceuticals, Inc.; the most recent is dated Nov 17, 2021.
When was Noven Pharmaceuticals, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Noven Pharmaceuticals, Inc. is a Form 483 dated Nov 17, 2021, for the site in Miami, Florida.
What did FDA cite at Noven Pharmaceuticals, Inc.?
The regulations cited most in the observations on file for Noven Pharmaceuticals, Inc. are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.46 (Ventilation, air filtration, air heating and cooling), 1 time.
Has Noven Pharmaceuticals, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Noven Pharmaceuticals, Inc.; the most recent is dated Aug 5, 2016.