Jacobus Pharmaceutical Company, Inc.
Form 483 issued June 27, 2014 · Plainsboro, Alabama
- Inspection
- Jun 23 – Jun 27, 2014
- Investigator
- Claire M. Minden
- Observations
- 8
- Pages
- 4
- FEI number
- 2243092
In short: On June 27, 2014, FDA issued a Form 483 with 8 observations to Jacobus Pharmaceutical Company, Inc. in Plainsboro, Alabama (FEI 2243092) after an inspection that ran Jun 23 – Jun 27, 2014. The investigator was Claire M. Minden. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 04
Written procedures describing the handling ofcomplaints do not include provisions for review by the qua lity…
This inspection in context
Claire M. Minden
26 documents · 2013–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Louisiana.
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 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Jacobus Pharmaceutical Company, Inc.?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, production and materials. The opening words of each observation are shown on this page.
Who inspected Jacobus Pharmaceutical Company, Inc.?
Claire M. Minden is named on this Form 483, for the inspection of Jun 23 – Jun 27, 2014. Each investigator has a profile showing what they cite most.
When was Jacobus Pharmaceutical Company, Inc. inspected by FDA?
The inspection ran Jun 23 – Jun 27, 2014, and the Form 483 is dated June 27, 2014.
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.