PharMEDium Services LLC
Form 483 issued September 19, 2007 · Sugar Land, Texas
- Inspection
- Sep 4 – Sep 19, 2007
- Investigators
- Daniel J. Lahar· Stephen D. Brown
- Observations
- 7
- Pages
- 5
- FEI number
- 3000717703
In short: On September 19, 2007, FDA issued a Form 483 with 7 observations to PharMEDium Services LLC in Sugar Land, Texas (FEI 3000717703) after an inspection that ran Sep 4 – Sep 19, 2007. The investigators were Daniel J. Lahar and Stephen D. Brown.
What FDA observed
Preview: the opening words of each observation- 01
firm's sampling and testing plan for sterility and potency testing of manufactured lots of sterile drug…
- 02
he firm's procedure for sanitizing supplies and equipment used to manufacture lots of sterile drug products…
- 03
firm's disinfectant effectiveness studies do not include microbial challenge (microbial studies to demonstrate that and are…
- 04
firm does not conduct on-going stability studies for any finished drug products which are and distributed…
This inspection in context
Daniel J. Lahar
3 documents · 2007–2025
Cites 820.30 (design controls) 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.
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Questions about this 483
What did FDA find at PharMEDium Services LLC?
FDA listed 7 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected PharMEDium Services LLC?
Daniel J. Lahar and Stephen D. Brown are named on this Form 483, for the inspection of Sep 4 – Sep 19, 2007. Each investigator has a profile showing what they cite most.
When was PharMEDium Services LLC inspected by FDA?
The inspection ran Sep 4 – Sep 19, 2007, and the Form 483 is dated September 19, 2007.
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.