PharMEDium Services, LLC
Form 483 issued November 4, 2015 · Cleveland, Mississippi
- Inspection
- Jan 25 – Jan 27, 2006
- Investigator
- Steven D. Dittert
- Observations
- 9
- Pages
- 2
- FEI number
- 3004153061
In short: On November 4, 2015, FDA issued a Form 483 with 9 observations to PharMEDium Services, LLC in Cleveland, Mississippi (FEI 3004153061) after an inspection that ran Jan 25 – Jan 27, 2006. The investigator was Steven D. Dittert. Most observations concern laboratory controls and quality system.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to perform finished product testing for identity, potency, and sterility as a requirement for release…
- 02
The quality control unit is not designated in writing and given the responsibility and authority to…
- 03
Finished product quarantine and release procedures are inadequate in that (b)(4) units of lot #060120087, 0.2…
- 04
In process product is not adequately labeled to identify the…
This inspection in context
Steven D. Dittert
1 document · 2015
Cites 211.105 (equipment identification) more than any other section. Most of their documents are for sites in Mississippi.
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 211.165
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 laboratory controls, quality system and materials. The opening words of each observation are shown on this page.
Who inspected PharMEDium Services, LLC?
Steven D. Dittert is named on this Form 483, for the inspection of Jan 25 – Jan 27, 2006. Each investigator has a profile showing what they cite most.
When was PharMEDium Services, LLC inspected by FDA?
The inspection ran Jan 25 – Jan 27, 2006, and the Form 483 is dated November 4, 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.