LSNE-Leon, SLU, D/B/A: PCI Pharma Services
Form 483 issued October 16, 2018 · León, Spain
- Inspection
- Oct 8 – Oct 16, 2018
- Investigators
- Aditi S. Thakur· Kham Phommachanh
- Observations
- 3
- Pages
- 3
- FEI number
- 3011566408
In short: On October 16, 2018, FDA issued a Form 483 with 3 observations to LSNE-Leon, SLU, D/B/A: PCI Pharma Services in León, Spain (FEI 3011566408) after an inspection that ran Oct 8 – Oct 16, 2018. The investigators were Aditi S. Thakur and Kham Phommachanh. Most observations concern packaging & labeling; the most-cited regulation is 21 CFR 211.122 (materials examination and usage criteria).
At a glance
2 of 3 observations on this 483 concern packaging & labeling.
Most cited: 21 CFR 211.122 (1×) · 211.130 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The information stated in the submitted drug application is not exactly…
- 02
Labeling equipment is not qualified in preparation for…
- 03
There are no established…
This inspection in context
Aditi S. Thakur
4 documents · 2018–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmLSNE-Leon, SLU, D/B/A: PCI Pharma Services history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.122
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at LSNE-Leon, SLU, D/B/A: PCI Pharma Services?
FDA listed 3 observations on this Form 483, mostly about packaging & labeling. The most-cited regulation is 21 CFR 211.122 (materials examination and usage criteria). The opening words of each observation are shown on this page.
Who inspected LSNE-Leon, SLU, D/B/A: PCI Pharma Services?
Aditi S. Thakur and Kham Phommachanh are named on this Form 483, for the inspection of Oct 8 – Oct 16, 2018. Each investigator has a profile showing what they cite most.
When was LSNE-Leon, SLU, D/B/A: PCI Pharma Services inspected by FDA?
The inspection ran Oct 8 – Oct 16, 2018, and the Form 483 is dated October 16, 2018.
How do I get the full Form 483 for LSNE-Leon, SLU, D/B/A: PCI Pharma Services?
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.