PharMEDium Services LLC
Form 483 issued February 28, 2013 · Edison, New Jersey
- Inspection
- Feb 20 – Feb 28, 2013
- Investigators
- James A. Liubicich· Russell J. Glapion
- Observations
- 7
- Pages
- 3
- FEI number
- 2242985
In short: On February 28, 2013, FDA issued a Form 483 with 7 observations to PharMEDium Services LLC in Edison, New Jersey (FEI 2242985) after an inspection that ran Feb 20 – Feb 28, 2013. The investigators were James A. Liubicich and Russell J. Glapion. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Clothing of personnel engaged in the processing of drug products is not appropriate for…
- 02
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
An adequate number of batches of each drug product are not tested to determine…
This inspection in context
James A. Liubicich
13 documents · 2013–2015
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmPharMEDium Services LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.28(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PharMEDium Services LLC?
FDA listed 7 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 PharMEDium Services LLC?
James A. Liubicich and Russell J. Glapion are named on this Form 483, for the inspection of Feb 20 – Feb 28, 2013. Each investigator has a profile showing what they cite most.
When was PharMEDium Services LLC inspected by FDA?
The inspection ran Feb 20 – Feb 28, 2013, and the Form 483 is dated February 28, 2013.
How do I get the full Form 483 for PharMEDium Services 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.