Exela Pharma Sciences, LLC
Form 483 issued September 28, 2017 · Lenoir, North Carolina
- Inspection
- Sep 19 – Sep 28, 2017
- Investigator
- Rachael Moliver
- Observations
- 6
- Pages
- 4
- FEI number
- 3008563008
In short: On September 28, 2017, FDA issued a Form 483 with 6 observations to Exela Pharma Sciences, LLC in Lenoir, North Carolina (FEI 3008563008) after an inspection that ran Sep 19 – Sep 28, 2017. The investigator was Rachael Moliver. Most observations concern facilities & equipment and packaging & labeling.
At a glance
Facilities & equipment and packaging & labeling account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
There was a failure to handle and store components and drug product containers at al l…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Routine checking of electronic equipment is not performed according to a written program designed…
- 04
The results of the examination of the packaged and labeled products were not documented in the…
This inspection in context
Rachael Moliver
13 documents · 2016–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
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 211.80(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Exela Pharma Sciences, LLC?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, packaging & labeling and materials. The opening words of each observation are shown on this page.
Who inspected Exela Pharma Sciences, LLC?
Rachael Moliver is named on this Form 483, for the inspection of Sep 19 – Sep 28, 2017. Each investigator has a profile showing what they cite most.
When was Exela Pharma Sciences, LLC inspected by FDA?
The inspection ran Sep 19 – Sep 28, 2017, and the Form 483 is dated September 28, 2017.
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.