PharMEDium Services, LLC
Form 483 issued February 22, 2013 · Cleveland, Mississippi
- Inspection
- Feb 20 – Feb 22, 2013
- Investigators
- Dell S. Moller· Marvin D. Jones
- Observations
- 13
- Pages
- 5
- FEI number
- 3004153061
In short: On February 22, 2013, FDA issued a Form 483 with 13 observations to PharMEDium Services, LLC in Cleveland, Mississippi (FEI 3004153061) after an inspection that ran Feb 20 – Feb 22, 2013. The investigators were Dell S. Moller and Marvin D. Jones. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Facilities & equipment and laboratory controls account for 8 of 13 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
The production area air supply lacks an…
- 02
Each batch ofdrug product purporting to be sterile and pyrogen-free is not laboratory tested to determine…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 04
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Dell S. Moller
3 documents · 2011–2013
Cites 211.113 (control of microbiological contamination) 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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PharMEDium Services, LLC?
FDA listed 13 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected PharMEDium Services, LLC?
Dell S. Moller and Marvin D. Jones are named on this Form 483, for the inspection of Feb 20 – Feb 22, 2013. Each investigator has a profile showing what they cite most.
When was PharMEDium Services, LLC inspected by FDA?
The inspection ran Feb 20 – Feb 22, 2013, and the Form 483 is dated February 22, 2013.
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.