Exela Pharma Sciences, LLC
Form 483 issued March 29, 2019 · Lenoir, North Carolina
- Inspection
- Mar 18 – Mar 29, 2019
- Investigators
- Jason R. Caballero· Samantha J. Bradley
- Observations
- 10
- Pages
- 8
- FEI number
- 3008563008
In short: On March 29, 2019, FDA issued a Form 483 with 10 observations to Exela Pharma Sciences, LLC in Lenoir, North Carolina (FEI 3008563008) after an inspection that ran Mar 18 – Mar 29, 2019. The investigators were Jason R. Caballero and Samantha J. Bradley. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 6 of 10 observations.
Most cited: 21 CFR 211.42 (3×) · 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 02
Routine inspection and checking of automatic, mechanical and electronic equipment is not performed according to a…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment…
This inspection in context
Jason R. Caballero
26 documents · 2014–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Exela Pharma Sciences, LLC?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Exela Pharma Sciences, LLC?
Jason R. Caballero and Samantha J. Bradley are named on this Form 483, for the inspection of Mar 18 – Mar 29, 2019. Each investigator has a profile showing what they cite most.
When was Exela Pharma Sciences, LLC inspected by FDA?
The inspection ran Mar 18 – Mar 29, 2019, and the Form 483 is dated March 29, 2019.
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.