LUSOMEDICAMENTA - SOCIEDADE TECNICA FARMACEUTICA, S.A.
Form 483 issued September 27, 2019 · Barcarena, Portugal
- Inspection
- Sep 23 – Sep 27, 2019
- Investigator
- Yasamin Ameri
- Observations
- 5
- Pages
- 5
- FEI number
- 3005491771
In short: On September 27, 2019, FDA issued a Form 483 with 5 observations to LUSOMEDICAMENTA - SOCIEDADE TECNICA FARMACEUTICA, S.A. in Barcarena, Portugal (FEI 3005491771) after an inspection that ran Sep 23 – Sep 27, 2019. The investigator was Yasamin Ameri. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and laboratory controls account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are…
- 02
Sampling procedures are deficient regarding sampling components from the top, middle, and bottom of container. Farmaceutica…
- 03
Written production and process control procedures are not followed in the execution of production…
- 04
Changes to written procedures are not reviewed and approved by…
This inspection in context
Yasamin Ameri
20 documents · 2015–2022
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in India.
The firmLUSOMEDICAMENTA - SOCIEDADE TECNICA FARMACEUTICA, S.A. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160(b)(4)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at LUSOMEDICAMENTA - SOCIEDADE TECNICA FARMACEUTICA, S.A.?
FDA listed 5 observations on this Form 483, mostly about production, laboratory controls and materials. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected LUSOMEDICAMENTA - SOCIEDADE TECNICA FARMACEUTICA, S.A.?
Yasamin Ameri is named on this Form 483, for the inspection of Sep 23 – Sep 27, 2019. Each investigator has a profile showing what they cite most.
When was LUSOMEDICAMENTA - SOCIEDADE TECNICA FARMACEUTICA, S.A. inspected by FDA?
The inspection ran Sep 23 – Sep 27, 2019, and the Form 483 is dated September 27, 2019.
How do I get the full Form 483 for LUSOMEDICAMENTA - SOCIEDADE TECNICA FARMACEUTICA, 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.