PharMEDium Services LLC
Form 483 issued July 13, 2015 · Edison, New Jersey
- Inspection
- Jun 12 – Jul 13, 2015
- Investigator
- Barbara J. Wilimczyk-Macri
- Observations
- 10
- Pages
- 5
- FEI number
- 2242985
In short: On July 13, 2015, FDA issued a Form 483 with 10 observations to PharMEDium Services LLC in Edison, New Jersey (FEI 2242985) after an inspection that ran Jun 12 – Jul 13, 2015. The investigator was Barbara J. Wilimczyk-Macri. Most observations concern facilities & equipment and quality system; 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
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Employees engaged in the manufacture, processing, packing, and holding of a drug product lack the training…
- 03
The control systems necessary to prevent contamination…
- 04
The flow of components, drug product containers, closures, in-process materials, and drug products though the building…
This inspection in context
Barbara J. Wilimczyk-Macri
5 documents · 2012–2016
Cites 211.42 (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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PharMEDium Services LLC?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. 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. Wilimczyk-Macri is named on this Form 483, for the inspection of Jun 12 – Jul 13, 2015. Each investigator has a profile showing what they cite most.
When was PharMEDium Services LLC inspected by FDA?
The inspection ran Jun 12 – Jul 13, 2015, and the Form 483 is dated July 13, 2015.
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.