Laboratorios Farmalan, S.A.
Form 483 issued March 19, 2019 · VILLAQUILAMBRE, Spain
- Inspection
- Mar 11 – Mar 19, 2019
- Investigator
- Michael A. Charles
- Observations
- 5
- Pages
- 6
- FEI number
- 3014424887
In short: On March 19, 2019, FDA issued a Form 483 with 5 observations to Laboratorios Farmalan, S.A. in VILLAQUILAMBRE, Spain (FEI 3014424887) after an inspection that ran Mar 11 – Mar 19, 2019. The investigator was Michael A. Charles. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Facilities & equipment and quality system account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up. a)…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Equipment for adequate control over micro-organisms and humidity is not provided when appropriate for the manufacture…
This inspection in context
Michael A. Charles
29 documents · 2013–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
The firmLaboratorios Farmalan, S.A. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Laboratorios Farmalan, S.A.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Laboratorios Farmalan, S.A.?
Michael A. Charles is named on this Form 483, for the inspection of Mar 11 – Mar 19, 2019. Each investigator has a profile showing what they cite most.
When was Laboratorios Farmalan, S.A. inspected by FDA?
The inspection ran Mar 11 – Mar 19, 2019, and the Form 483 is dated March 19, 2019.
How do I get the full Form 483 for Laboratorios Farmalan, S.A.?
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.