Exela Pharma Sciences, LLC
Form 483 issued July 18, 2019 · Lenoir, North Carolina
- Inspection
- Jun 10 – Jul 18, 2019
- Investigator
- Samantha J. Bradley
- Observations
- 7
- Pages
- 8
- FEI number
- 3008563008
In short: On July 18, 2019, FDA issued a Form 483 with 7 observations to Exela Pharma Sciences, LLC in Lenoir, North Carolina (FEI 3008563008) after an inspection that ran Jun 10 – Jul 18, 2019. The investigator was Samantha J. Bradley. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 5 of 7 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 04
Drug product containers and closures were not sterilized and processed to remove pyrogenic properties to assure…
This inspection in context
Samantha J. Bradley
14 documents · 2013–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Alabama.
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(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 7 observations on this Form 483, mostly about production, facilities & equipment and materials. 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?
Samantha J. Bradley is named on this Form 483, for the inspection of Jun 10 – Jul 18, 2019. Each investigator has a profile showing what they cite most.
When was Exela Pharma Sciences, LLC inspected by FDA?
The inspection ran Jun 10 – Jul 18, 2019, and the Form 483 is dated July 18, 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.