Sewaren Innovative Pharmaceutical Packaging dba SIPP
Form 483 issued July 19, 2016 · Avenel, New Jersey
- Inspection
- Apr 18 – Jun 28, 2016
- Investigators
- Melissa T. Roy· Nancy F. Scheraga· Zakaria I. Ganiyu
- Observations
- 3
- Pages
- 3
- FEI number
- 3012292690
In short: On July 19, 2016, FDA issued a Form 483 with 3 observations to Sewaren Innovative Pharmaceutical Packaging dba SIPP in Avenel, New Jersey (FEI 3012292690) after an inspection that ran Apr 18 – Jun 28, 2016. The investigators were Melissa T. Roy, Nancy F. Scheraga and Zakaria I. Ganiyu. Most observations concern packaging & labeling and laboratory controls.
At a glance
Packaging & labeling and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
This inspection in context
Melissa T. Roy
6 documents · 2016–2018
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in New Jersey.
The firmSewaren Innovative Pharmaceutical Packaging dba SIPP history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.137(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sewaren Innovative Pharmaceutical Packaging dba SIPP?
FDA listed 3 observations on this Form 483, mostly about packaging & labeling, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Sewaren Innovative Pharmaceutical Packaging dba SIPP?
Melissa T. Roy, Nancy F. Scheraga and Zakaria I. Ganiyu are named on this Form 483, for the inspection of Apr 18 – Jun 28, 2016. Each investigator has a profile showing what they cite most.
When was Sewaren Innovative Pharmaceutical Packaging dba SIPP inspected by FDA?
The inspection ran Apr 18 – Jun 28, 2016, and the Form 483 is dated July 19, 2016.
How do I get the full Form 483 for Sewaren Innovative Pharmaceutical Packaging dba SIPP?
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.