Exela Pharma Sciences, LLC
Form 483 issued November 21, 2014 · Lenoir, Georgia
- Inspection
- Nov 21, 2014
- Investigators
- Brett Weed· Noreen Muniz
- Observations
- 1
- Pages
- 2
- FEI number
- 3008563008
In short: On November 21, 2014, FDA issued a Form 483 with 1 observation to Exela Pharma Sciences, LLC in Lenoir, Georgia (FEI 3008563008) after an inspection that ran Nov 21, 2014. The investigators were Brett Weed and Noreen Muniz. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
This inspection in context
Brett Weed
1 document · 2014
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Georgia.
The firmExela Pharma Sciences, LLC history
All 10 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Exela Pharma Sciences, LLC?
FDA listed 1 observation on this Form 483, mostly about 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 Exela Pharma Sciences, LLC?
Brett Weed and Noreen Muniz are named on this Form 483, for the inspection of Nov 21, 2014. Each investigator has a profile showing what they cite most.
When was Exela Pharma Sciences, LLC inspected by FDA?
The inspection ran Nov 21, 2014, and the Form 483 is dated November 21, 2014.
How do I get the full Form 483 for Exela Pharma Sciences, 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.