PharMEDium Services, LLC
Form 483 issued July 16, 2015 · Cleveland, Mississippi
- Inspection
- Jul 6 – Jul 16, 2015
- Investigator
- Claire M. Minden
- Observations
- 9
- Pages
- 5
- FEI number
- 3004153061
In short: On July 16, 2015, FDA issued a Form 483 with 9 observations to PharMEDium Services, LLC in Cleveland, Mississippi (FEI 3004153061) after an inspection that ran Jul 6 – Jul 16, 2015. The investigator was Claire M. Minden. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
This inspection in context
Claire M. Minden
26 documents · 2013–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Louisiana.
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
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, production 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?
Claire M. Minden is named on this Form 483, for the inspection of Jul 6 – Jul 16, 2015. Each investigator has a profile showing what they cite most.
When was PharMEDium Services, LLC inspected by FDA?
The inspection ran Jul 6 – Jul 16, 2015, and the Form 483 is dated July 16, 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.