PharMEDium Services, LLC
Form 483 issued July 10, 2015 · Memphi s, Tennessee
- Inspection
- Jun 22 – Jul 10, 2015
- Investigators
- Ivy E. Sweeney· Zada L. Giles
- Observations
- 11
- Pages
- 8
- FEI number
- 3007045542
In short: On July 10, 2015, FDA issued a Form 483 with 11 observations to PharMEDium Services, LLC in Memphi s, Tennessee (FEI 3007045542) after an inspection that ran Jun 22 – Jul 10, 2015. The investigators were Ivy E. Sweeney and Zada L. Giles. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Laboratory controls and facilities & equipment account for 7 of 11 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Ivy E. Sweeney
1 document · 2015
Cites 211.113(b) (control of microbiological contamination) more than any other section. Most of their documents are for sites in Tennessee.
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 11 observations on this Form 483, mostly about laboratory controls, facilities & equipment 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?
Ivy E. Sweeney and Zada L. Giles are named on this Form 483, for the inspection of Jun 22 – Jul 10, 2015. Each investigator has a profile showing what they cite most.
When was PharMEDium Services, LLC inspected by FDA?
The inspection ran Jun 22 – Jul 10, 2015, and the Form 483 is dated July 10, 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.