Pharmaceutical Innovations, Inc
FDA inspection history in Newark, New Jersey, 2011 to 2019
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2011: one warning letter; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2011One warning letter, at Newark, New Jersey.
- 2019One Form 483, at Newark, New Jersey.
Cited most
Across all Pharmaceutical Innovations observations on file
- 21 CFR 820.30(i)Design controls2
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.181Device master record1
- 21 CFR 820.184Device history record1
- 21 CFR 820.40Document controls1
The complete Pharmaceutical Innovations 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
Newark, New Jersey
One Form 483 and one warning letter · 2011 to 2019 · 11 observations
Latest: Form 483, May 29, 2019 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-05-29 | 483 Form 483 | Newark, New Jersey | 11 | $99 |
| 2011-07-29 | Warning letter Warning letter | Newark, New Jersey | — | $99 |
Investigators on these documents
Gobiga Vanniyasingam (1)Melissa A. Zuppe (1)Phillip M. Pontikos (1)
FEI number 2241583 · most recent document May 29, 2019
About Pharmaceutical Innovations, Inc
How many FDA Form 483s has Pharmaceutical Innovations, Inc received?
FDA Intel has 1 Form 483 on file for Pharmaceutical Innovations, Inc; the most recent is dated May 29, 2019.
When was Pharmaceutical Innovations, Inc last inspected by FDA?
The most recent FDA inspection document on file for Pharmaceutical Innovations, Inc is a Form 483 dated May 29, 2019, for the site in Newark, New Jersey.
What did FDA cite at Pharmaceutical Innovations, Inc?
The regulations cited most in the observations on file for Pharmaceutical Innovations, Inc are 21 CFR 820.30(i) (Design controls), 2 times; 21 CFR 820.100(a) (Corrective and preventive action), 1 time; 21 CFR 820.181 (Device master record), 1 time.
Has Pharmaceutical Innovations, Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Pharmaceutical Innovations, Inc; the most recent is dated Jul 29, 2011.