LSNE-Leon, SLU, D/B/A: PCI Pharma Services
Form 483 issued September 19, 2023 · LEON, Spain
- Inspection
- Sep 11 – Sep 19, 2023
- Investigator
- Saundrea A. Munroe
- Observations
- 4
- Pages
- 4
- FEI number
- 3011566408
In short: On September 19, 2023, FDA issued a Form 483 with 4 observations to LSNE-Leon, SLU, D/B/A: PCI Pharma Services in LEON, Spain (FEI 3011566408) after an inspection that ran Sep 11 – Sep 19, 2023. The investigator was Saundrea A. Munroe. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the…
- 02
Written records of investigations into the failure of a batch or any of its components to…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Establishment of the reliability of the component supplier's report of analyses is deficient in that the…
This inspection in context
Saundrea A. Munroe
30 documents · 2018–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Florida.
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 211.67
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 4 observations on this Form 483, mostly about quality system, facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected LSNE-Leon, SLU, D/B/A: PCI Pharma Services?
Saundrea A. Munroe is named on this Form 483, for the inspection of Sep 11 – Sep 19, 2023. 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 Sep 11 – Sep 19, 2023, and the Form 483 is dated September 19, 2023.
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.