PharMEDium Services LLC
Form 483 issued May 26, 2016 · Edison, New Jersey
- Inspection
- Apr 18 – May 26, 2016
- Investigators
- Barbara J. Wiliwtczyk-Macri· Mina Ahmadi· Nicholas Violand
- Observations
- 9
- Pages
- 8
- FEI number
- 2242985
In short: On May 26, 2016, FDA issued a Form 483 with 9 observations to PharMEDium Services LLC in Edison, New Jersey (FEI 2242985) after an inspection that ran Apr 18 – May 26, 2016. The investigators were Barbara J. Wiliwtczyk-Macri, Mina Ahmadi and Nicholas Violand. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 02
Each batch of drug product pwporting to be sterile and pyrogen-ftee iS not laboratory t~ to…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Barbara J. Wiliwtczyk-Macri
1 document · 2016
Cites 211.42(c)(10)(iv) (design and construction features) more than any other section. Most of their documents are for sites in New Jersey.
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 211.42(c)(10)(vi)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PharMEDium Services LLC?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected PharMEDium Services LLC?
Barbara J. Wiliwtczyk-Macri, Mina Ahmadi and Nicholas Violand are named on this Form 483, for the inspection of Apr 18 – May 26, 2016. Each investigator has a profile showing what they cite most.
When was PharMEDium Services LLC inspected by FDA?
The inspection ran Apr 18 – May 26, 2016, and the Form 483 is dated May 26, 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.