PharMEDium Services LLC
Form 483 issued November 10, 2010 · Sugar Land, Texas
- Inspection
- Nov 10, 2010
- Investigator
- Stephen D. Brown
- Observations
- 3
- Pages
- 2
- FEI number
- 3000717703
In short: On November 10, 2010, FDA issued a Form 483 with 3 observations to PharMEDium Services LLC in Sugar Land, Texas (FEI 3000717703) after an inspection that ran Nov 10, 2010. The investigator was Stephen D. Brown. Most observations concern production and quality system.
At a glance
Production and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Review of complaints for the period between 3/2010 and the present revealed that your firm had…
- 02
Your firm does not maintain an approved master compounding record which documents the concentration range detennination…
- 03
SOP #CPS-707 entitled, "Microbiological and Environmental Testing" (Effective date: 6/16/1 0) documents, in ·that -a MiCrobiological…
This inspection in context
Stephen D. Brown
42 documents · 2006–2021
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmPharMEDium Services LLC history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.186
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PharMEDium Services LLC?
FDA listed 3 observations on this Form 483, mostly about production and quality system. The opening words of each observation are shown on this page.
Who inspected PharMEDium Services LLC?
Stephen D. Brown is named on this Form 483, for the inspection of Nov 10, 2010. Each investigator has a profile showing what they cite most.
When was PharMEDium Services LLC inspected by FDA?
The inspection ran Nov 10, 2010, and the Form 483 is dated November 10, 2010.
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.