Jacobus Pharmaceutical Company, Inc.
Form 483 issued April 23, 2025 · PLAINSBORO, New Jersey
- Inspection
- Apr 14 – Apr 23, 2025
- Investigators
- Jessica S. Estriplet· Suchan Kim
- Observations
- 6
- Pages
- 7
- FEI number
- 2243092
In short: On April 23, 2025, FDA issued a Form 483 with 6 observations to Jacobus Pharmaceutical Company, Inc. in PLAINSBORO, New Jersey (FEI 2243092) after an inspection that ran Apr 14 – Apr 23, 2025. The investigators were Jessica S. Estriplet and Suchan Kim. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and production account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
Routine checking of equipment is not performed according to a written program designed…
- 03
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test…
This inspection in context
Jessica S. Estriplet
18 documents · 2021–2026
Cites 211.22 (responsibilities of quality control unit) 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 483sOther sites cited under 211.100(a)
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, production and laboratory controls. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Jacobus Pharmaceutical Company, Inc.?
Jessica S. Estriplet and Suchan Kim are named on this Form 483, for the inspection of Apr 14 – Apr 23, 2025. Each investigator has a profile showing what they cite most.
When was Jacobus Pharmaceutical Company, Inc. inspected by FDA?
The inspection ran Apr 14 – Apr 23, 2025, and the Form 483 is dated April 23, 2025.
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.