Pharmaceutical Innovations, Inc
Form 483 issued May 29, 2019 · Newark, New Jersey
- Inspection
- Apr 15 – May 29, 2019
- Investigators
- Gobiga Vanniyasingam· Melissa A. Zuppe· Phillip M. Pontikos
- Observations
- 11
- Pages
- 12
- FEI number
- 2241583
In short: On May 29, 2019, FDA issued a Form 483 with 11 observations to Pharmaceutical Innovations, Inc in Newark, New Jersey (FEI 2241583) after an inspection that ran Apr 15 – May 29, 2019. The investigators were Gobiga Vanniyasingam, Melissa A. Zuppe and Phillip M. Pontikos. Most observations concern production & process controls and records & documents; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Production & process controls and records & documents account for 7 of 11 observations.
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Procedures have not been adequately established to control product that does not…
- 03
Procedures for the acceptance and control of in-process product have…
- 04
Procedures for design change have…
This inspection in context
Gobiga Vanniyasingam
4 documents · 2018–2019
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in New Jersey.
The firmPharmaceutical Innovations, 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 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmaceutical Innovations, Inc?
FDA listed 11 observations on this Form 483, mostly about production & process controls, records & documents and cAPA. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Pharmaceutical Innovations, Inc?
Gobiga Vanniyasingam, Melissa A. Zuppe and Phillip M. Pontikos are named on this Form 483, for the inspection of Apr 15 – May 29, 2019. Each investigator has a profile showing what they cite most.
When was Pharmaceutical Innovations, Inc inspected by FDA?
The inspection ran Apr 15 – May 29, 2019, and the Form 483 is dated May 29, 2019.
How do I get the full Form 483 for Pharmaceutical Innovations, 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.