Hereon Pharmaceuticals, LLC
Form 483 issued April 5, 2019 · Emigsville, Pennsylvania
- Inspection
- Apr 1 – Apr 5, 2019
- Investigator
- Mindy M. Chou
- Observations
- 3
- Pages
- 2
- FEI number
- 2522638
In short: On April 5, 2019, FDA issued a Form 483 with 3 observations to Hereon Pharmaceuticals, LLC in Emigsville, Pennsylvania (FEI 2522638) after an inspection that ran Apr 1 – Apr 5, 2019. The investigator was Mindy M. Chou. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
The use of instruments not meeting…
- 03
Routine calibration of mechanical equipment is not performed according to a written program designed…
This inspection in context
Mindy M. Chou
37 documents · 2015–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in New York.
The firmHereon Pharmaceuticals, LLC history
The site's inspection history, in date order.
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 Hereon Pharmaceuticals, LLC?
FDA listed 3 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Hereon Pharmaceuticals, LLC?
Mindy M. Chou is named on this Form 483, for the inspection of Apr 1 – Apr 5, 2019. Each investigator has a profile showing what they cite most.
When was Hereon Pharmaceuticals, LLC inspected by FDA?
The inspection ran Apr 1 – Apr 5, 2019, and the Form 483 is dated April 5, 2019.
How do I get the full Form 483 for Hereon Pharmaceuticals, LLC?
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.