PharMEDium Services LLC
Form 483 issued September 24, 2015 · Sugar Land, Texas
- Inspection
- Aug 24 – Sep 24, 2015
- Investigators
- Camerson E. Moore· Jason R. Caballero· Stephen D. Brown
- Observations
- 7
- Pages
- 6
- FEI number
- 3000717703
In short: On September 24, 2015, FDA issued a Form 483 with 7 observations to PharMEDium Services LLC in Sugar Land, Texas (FEI 3000717703) after an inspection that ran Aug 24 – Sep 24, 2015. The investigators were Camerson E. Moore, Jason R. Caballero and Stephen D. Brown. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Each batch or drug product purporting to be sterile and pyrogen-free is not laboratory tested 10…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Camerson E. Moore
48 documents · 2014–2026
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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PharMEDium Services LLC?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected PharMEDium Services LLC?
Camerson E. Moore, Jason R. Caballero and Stephen D. Brown are named on this Form 483, for the inspection of Aug 24 – Sep 24, 2015. Each investigator has a profile showing what they cite most.
When was PharMEDium Services LLC inspected by FDA?
The inspection ran Aug 24 – Sep 24, 2015, and the Form 483 is dated September 24, 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.