PharMEDium Services LLC
Form 483 issued February 27, 2013 · Sugar Land, Texas
- Inspection
- Feb 19 – Feb 27, 2013
- Investigators
- Scott Ballard· Stephen D. Brown
- Observations
- 9
- Pages
- 8
- FEI number
- 3000717703
In short: On February 27, 2013, FDA issued a Form 483 with 9 observations to PharMEDium Services LLC in Sugar Land, Texas (FEI 3000717703) after an inspection that ran Feb 19 – Feb 27, 2013. The investigators were Scott Ballard and Stephen D. Brown. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and production account for 7 of 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
- 02
Clothing of personnel engaged in the manufacturing of drug products is not appropriate for…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 04
Each batch of drug product required to be free of objectionable microorganisms is not tested…
This inspection in context
Scott Ballard
30 documents · 2011–2025
Cites 211.42 (design and construction features) 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 211.67(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PharMEDium Services LLC?
FDA listed 9 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected PharMEDium Services LLC?
Scott Ballard and Stephen D. Brown are named on this Form 483, for the inspection of Feb 19 – Feb 27, 2013. Each investigator has a profile showing what they cite most.
When was PharMEDium Services LLC inspected by FDA?
The inspection ran Feb 19 – Feb 27, 2013, and the Form 483 is dated February 27, 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.