Laboratorios Leon Farma SAU
Form 483 issued May 25, 2018 · VILLAQUILAMBRE, Spain
- Inspection
- May 7 – May 25, 2018
- Observations
- 7
- Pages
- 48
- FEI number
- 3006188375
In short: On May 25, 2018, FDA issued a Form 483 with 7 observations to Laboratorios Leon Farma SAU in VILLAQUILAMBRE, Spain (FEI 3006188375) after an inspection that ran May 7 – May 25, 2018. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.184 (device history record).
At a glance
CAPA and production & process controls account for 5 of 7 observations.
Most cited: 21 CFR 820.184 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for corrective and preventive action have…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 03
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 04
Procedures for device history records…
This inspection in context
Questions about this 483
What did FDA find at Laboratorios Leon Farma SAU?
FDA listed 7 observations on this Form 483, mostly about cAPA, production & process controls and records & documents. The most-cited regulation is 21 CFR 820.184 (device history record). The opening words of each observation are shown on this page.
When was Laboratorios Leon Farma SAU inspected by FDA?
The inspection ran May 7 – May 25, 2018, and the Form 483 is dated May 25, 2018.
How do I get the full Form 483 for Laboratorios Leon Farma SAU?
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.