Jacobus Pharmaceutical Company, Inc.
Amended 483 issued February 18, 2011 · Plainsboro, New Jersey
- Inspection
- Feb 18, 2011
- Investigator
- Atul J. Agrawal
- Observations
- 10
- Pages
- 12
- FEI number
- 2243092
In short: On February 18, 2011, FDA issued a Amended 483 with 10 observations to Jacobus Pharmaceutical Company, Inc. in Plainsboro, New Jersey (FEI 2243092) after an inspection that ran Feb 18, 2011. The investigator was Atul J. Agrawal. Most observations concern quality system and facilities & equipment.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The written stability program for drug products does not include reliable, meaningful…
- 02
Your stability testing program is not designed to monitor the…
- 03
Your firm's quality unit is not involved in quality-related matters; the unit fails to review deviations…
- 04
Appropr iate controls are not establ…
6 more observations
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Atul J. Agrawal
5 documents · 2011–2018
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
The firmJacobus Pharmaceutical Company, Inc. history
All 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar documentsOther sites cited under 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at Jacobus Pharmaceutical Company, Inc.?
FDA listed 10 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Jacobus Pharmaceutical Company, Inc.?
Atul J. Agrawal is named on this Amended 483, for the inspection of Feb 18, 2011. Each investigator has a profile showing what they cite most.
When was Jacobus Pharmaceutical Company, Inc. inspected by FDA?
The inspection ran Feb 18, 2011, and the Amended 483 is dated February 18, 2011.
How do I get the full Amended 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.