PharMEDium Services, LLC
Form 483 issued March 22, 2013 · Memphi s, Tennessee
- Inspection
- Mar 18 – Mar 22, 2013
- Investigators
- Dell S. Moller· Marvin D. Jones
- Observations
- 10
- Pages
- 6
- FEI number
- 3007045542
In short: On March 22, 2013, FDA issued a Form 483 with 10 observations to PharMEDium Services, LLC in Memphi s, Tennessee (FEI 3007045542) after an inspection that ran Mar 18 – Mar 22, 2013. The investigators were Dell S. Moller and Marvin D. Jones. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Laboratory controls and production account for 7 of 10 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Written production and process control procedures are not followed in the execution of production…
- 02
The production area air supply lacks an…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
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 3 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 10 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. 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 Mar 18 – Mar 22, 2013. Each investigator has a profile showing what they cite most.
When was PharMEDium Services, LLC inspected by FDA?
The inspection ran Mar 18 – Mar 22, 2013, and the Form 483 is dated March 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.