Exela Pharma Sciences, LLC
Form 483 issued November 15, 2024 · Lenoir, North Carolina
- Investigators
- Ev Lin· Joan Cantellops· Logan T. Williams
- Observations
- 15
- Pages
- 19
- FEI number
- 3008563008
In short: On November 15, 2024, FDA issued a Form 483 with 15 observations to Exela Pharma Sciences, LLC in Lenoir, North Carolina (FEI 3008563008). The investigators were Ev Lin, Joan Cantellops, Logan T. Williams, Megan Ziegler and Santos E. Camara. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Laboratory controls and quality system account for 9 of 15 observations.
Most cited: 21 CFR 211.113 (2×) · 211.194 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies do not always include…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 04
Laboratory records do not include the initials or signature of a second person showing that the…
This inspection in context
Ev Lin
1 document · 2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in North Carolina.
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 15 observations on this Form 483, mostly about laboratory controls, quality system and 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?
Ev Lin, Joan Cantellops, Logan T. Williams, Megan Ziegler and Santos E. Camara are named on this Form 483. Each investigator has a profile showing what they cite most.
When was Exela Pharma Sciences, LLC inspected by FDA?
This Form 483 is dated November 15, 2024.
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.