Hovione Farmaciencia, S.A.
Form 483 issued June 28, 2024 · Loures, Portugal
- Inspection
- Jun 24 – Jun 28, 2024
- Investigators
- David A. Oluwo· Kenneth H. Williams
- Observations
- 6
- Pages
- 6
- FEI number
- 3002807208
In short: On June 28, 2024, FDA issued a Form 483 with 6 observations to Hovione Farmaciencia, S.A. in Loures, Portugal (FEI 3002807208) after an inspection that ran Jun 24 – Jun 28, 2024. The investigators were David A. Oluwo and Kenneth H. Williams. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 4 systems, led by laboratory controls.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 04
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are…
This inspection in context
David A. Oluwo
27 documents · 2017–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Maryland.
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 211.160
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 laboratory controls, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Hovione Farmaciencia, S.A.?
David A. Oluwo and Kenneth H. Williams are named on this Form 483, for the inspection of Jun 24 – Jun 28, 2024. Each investigator has a profile showing what they cite most.
When was Hovione Farmaciencia, S.A. inspected by FDA?
The inspection ran Jun 24 – Jun 28, 2024, and the Form 483 is dated June 28, 2024.
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.