PharMEDium Services LLC
Form 483 issued January 4, 2016 · Lake Forest, Illinois
- Inspection
- Nov 17, 2015 – Jan 4, 2016
- Investigator
- Christopher D. Leach
- Observations
- 6
- Pages
- 5
- FEI number
- 3005051736
In short: On January 4, 2016, FDA issued a Form 483 with 6 observations to PharMEDium Services LLC in Lake Forest, Illinois (FEI 3005051736) after an inspection that ran Nov 17, 2015 – Jan 4, 2016. The investigator was Christopher D. Leach. Most observations concern laboratory controls and materials.
At a glance
4 of 6 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Dmg product containers or closures are reactive so as to alter the safety, identity, strength, quality…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to…
- 04
Results of stability testing are not used…
This inspection in context
Christopher D. Leach
11 documents · 2013–2018
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Illinois.
The firmPharMEDium Services LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.94(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PharMEDium Services LLC?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, materials and quality system. The opening words of each observation are shown on this page.
Who inspected PharMEDium Services LLC?
Christopher D. Leach is named on this Form 483, for the inspection of Nov 17, 2015 – Jan 4, 2016. Each investigator has a profile showing what they cite most.
When was PharMEDium Services LLC inspected by FDA?
The inspection ran Nov 17, 2015 – Jan 4, 2016, and the Form 483 is dated January 4, 2016.
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.