Raritan Pharmaceuticals, Inc
FDA inspection history in East Brunswick, New Jersey, 2016 to 2018
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2016: one Form 483; 2017: one warning letter; 2018: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–18Two Form 483s and one warning letter, at East Brunswick, New Jersey.
- 2018The longest 483 on file: 5 observations over 6 pages at East Brunswick, New Jersey.
Cited most
Across all Raritan Pharmaceuticals observations on file
- 21 CFR 211.198Complaint files2
- 21 CFR 211.150Distribution procedures1
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.166(c)(1)Stability testing1
- 21 CFR 211.192Production record review1
The complete Raritan Pharmaceuticals file.
All 3 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
East Brunswick, New Jersey
Two Form 483s and one warning letter · 2016 to 2018 · 6 observations
Latest: Form 483, Jan 8, 2018 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-01-08 | 483 Form 483 | East Brunswick, New Jersey | 5 | $99 |
| 2017-06-20 | Warning letter Warning letter | East Brunswick, New Jersey | — | $99 |
| 2016-04-14 | 483 Form 483 | East Brunswick, New Jersey | 1 | $99 |
Investigators on these documents
FEI number 3004083931 · most recent document Jan 8, 2018
About Raritan Pharmaceuticals, Inc
How many FDA Form 483s has Raritan Pharmaceuticals, Inc received?
FDA Intel has 2 Form 483s on file for Raritan Pharmaceuticals, Inc; the most recent is dated Jan 8, 2018.
When was Raritan Pharmaceuticals, Inc last inspected by FDA?
The most recent FDA inspection document on file for Raritan Pharmaceuticals, Inc is a Form 483 dated Jan 8, 2018, for the site in East Brunswick, New Jersey.
What did FDA cite at Raritan Pharmaceuticals, Inc?
The regulations cited most in the observations on file for Raritan Pharmaceuticals, Inc are 21 CFR 211.198 (Complaint files), 2 times; 21 CFR 211.150 (Distribution procedures), 1 time; 21 CFR 211.160(b) (General requirements), 1 time.
Has Raritan Pharmaceuticals, Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Raritan Pharmaceuticals, Inc; the most recent is dated Jun 20, 2017.