LSNE-Leon, SLU, D/B/A: PCI Pharma Services
FDA inspection history across 2 sites, 2018 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at León, Spain.
- 2023One Form 483, at LEON, Spain.
- 2023The longest 483 on file: 4 observations over 4 pages at LEON, Spain.
Cited most
Across all LSNE-Leon, SLU, D/B/A: PCI Pharma Services observations on file
- 21 CFR 211.122Materials examination and usage criteria1
- 21 CFR 211.130Packaging and labeling operations1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete LSNE-Leon, SLU, D/B/A: PCI Pharma Services file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
LEON, Spain
One Form 483 · 2023 · 4 observations
Latest: Form 483, Sep 19, 2023 →León, Spain
One Form 483 · 2018 · 3 observations
Latest: Form 483, Oct 16, 2018 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-09-19 | 483 Form 483 | LEON, Spain | 4 | $99 |
| 2018-10-16 | 483 Form 483 | León, Spain | 3 | $99 |
Investigators on these documents
Aditi S. Thakur (1)Kham Phommachanh (1)Saundrea A. Munroe (1)
FEI number 3011566408 · most recent document Sep 19, 2023
About LSNE-Leon, SLU, D/B/A: PCI Pharma Services
How many FDA Form 483s has LSNE-Leon, SLU, D/B/A: PCI Pharma Services received?
FDA Intel has 2 Form 483s on file for LSNE-Leon, SLU, D/B/A: PCI Pharma Services; the most recent is dated Sep 19, 2023.
When was LSNE-Leon, SLU, D/B/A: PCI Pharma Services last inspected by FDA?
The most recent FDA inspection document on file for LSNE-Leon, SLU, D/B/A: PCI Pharma Services is a Form 483 dated Sep 19, 2023, for the site in LEON, Spain.
What did FDA cite at LSNE-Leon, SLU, D/B/A: PCI Pharma Services?
The regulations cited most in the observations on file for LSNE-Leon, SLU, D/B/A: PCI Pharma Services are 21 CFR 211.122 (Materials examination and usage criteria), 1 time; 21 CFR 211.130 (Packaging and labeling operations), 1 time; 21 CFR 211.192 (Production record review), 1 time.