Hovione Farmaciencia, S.A.
Form 483 issued March 17, 2017 · Loures, Portugal
- Inspection
- Mar 13 – Mar 17, 2017
- Investigators
- Deyaa Shaheen· Laura Fontan
- Observations
- 6
- Pages
- 4
- FEI number
- 3002807208
In short: On March 17, 2017, FDA issued a Form 483 with 6 observations to Hovione Farmaciencia, S.A. in Loures, Portugal (FEI 3002807208) after an inspection that ran Mar 13 – Mar 17, 2017. The investigators were Deyaa Shaheen and Laura Fontan. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
(Quality System) The responsibilities and procedures applicable to the quality control unit are not in…
- 02
(Quality System) Written procedures are not established/ followed for the OOS and deviation investigations, cleaning and…
- 03
(Laboratory System) Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures…
- 04
(Quality System) Employees engaged in the manufacture, processing, packing, and holding of a drug product lack…
This inspection in context
Deyaa Shaheen
5 documents · 2016–2017
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Germany.
The firmHovione Farmaciencia, S.A. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hovione Farmaciencia, S.A.?
FDA listed 6 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Hovione Farmaciencia, S.A.?
Deyaa Shaheen and Laura Fontan are named on this Form 483, for the inspection of Mar 13 – Mar 17, 2017. Each investigator has a profile showing what they cite most.
When was Hovione Farmaciencia, S.A. inspected by FDA?
The inspection ran Mar 13 – Mar 17, 2017, and the Form 483 is dated March 17, 2017.
How do I get the full Form 483 for Hovione Farmaciencia, 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.