Jacobus Pharmaceutical Company, Inc.
Form 483 issued April 16, 2012 · Plainsboro, New Jersey
- Inspection
- Mar 28 – Apr 16, 2012
- Investigator
- Aclial S. Reynolds
- Observations
- 6
- Pages
- 5
- FEI number
- 2343092
In short: On April 16, 2012, FDA issued a Form 483 with 6 observations to Jacobus Pharmaceutical Company, Inc. in Plainsboro, New Jersey (FEI 2343092) after an inspection that ran Mar 28 – Apr 16, 2012. The investigator was Aclial S. Reynolds. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is afailure to thoroughly investigate batches…
- 03
Faoilities used in the manufacture and storage of components, active phanntceutical fngredients, and…
- 04
Equipment used iii the manufacture of drog products are not…
- 06
Containers used during the production ofdrug products are not…
This inspection in context
Aclial S. Reynolds
1 document · 2012
Cites 211.105 (equipment identification) more than any other section. Most of their documents are for sites in New Jersey.
The firmJacobus Pharmaceutical Company, 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Jacobus Pharmaceutical Company, Inc.?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
Who inspected Jacobus Pharmaceutical Company, Inc.?
Aclial S. Reynolds is named on this Form 483, for the inspection of Mar 28 – Apr 16, 2012. Each investigator has a profile showing what they cite most.
When was Jacobus Pharmaceutical Company, Inc. inspected by FDA?
The inspection ran Mar 28 – Apr 16, 2012, and the Form 483 is dated April 16, 2012.
How do I get the full Form 483 for Jacobus Pharmaceutical Company, 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.