Exela Pharma Sciences, LLC

Form 483 issued November 4, 2024 · Lenoir, North Carolina

Inspection: Nov 4, 2024
Investigators: Joan Cantellops· Logan T. Williams· Megan Ziegler
Observations: 15
Pages: 19
FEI number: 3008563008

In short: On November 4, 2024, FDA issued a Form 483 with 15 observations to Exela Pharma Sciences, LLC in Lenoir, North Carolina (FEI 3008563008) after an inspection that ran Nov 4, 2024. The investigators were 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 10 of 15 observations.

Laboratory controls6

Quality system4

Production2

Facilities & equipment1

Other2

Most cited: 21 CFR 211.113 (2×) · 211.194 (2×)

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

01
21 CFR 211.192
Written records of investigations into unexplained discrepancies do not always include…
02
21 CFR 211.22
The responsibilities and procedures applicable to the quality control unit…
03
21 CFR 211.113
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
04
21 CFR 211.194
Laboratory records do not include the initials or signature of a second person showing that the…

11 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

The investigator

Joan Cantellops

2 documents · 2024

Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in North Carolina.

The firm

Exela Pharma Sciences, LLC history

All 10 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.113

See how FDA wrote the same problem up elsewhere.

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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?

Joan Cantellops, Logan T. Williams, Megan Ziegler and Santos E. Camara are named on this Form 483, for the inspection of Nov 4, 2024. Each investigator has a profile showing what they cite most.

When was Exela Pharma Sciences, LLC inspected by FDA?

The inspection ran Nov 4, 2024, and the Form 483 is dated November 4, 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.