HIKMA FARMACEUTICA (PORTUGAL), S.A
Form 483 issued April 21, 2023 · TERRUGEM SINTRA, Portugal
- Inspection
- Apr 13 – Apr 21, 2023
- Investigator
- Jose M. Cayuela
- Observations
- 7
- Pages
- 8
- FEI number
- 3002807173
In short: On April 21, 2023, FDA issued a Form 483 with 7 observations to HIKMA FARMACEUTICA (PORTUGAL), S.A in TERRUGEM SINTRA, Portugal (FEI 3002807173) after an inspection that ran Apr 13 – Apr 21, 2023. The investigator was Jose M. Cayuela. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and production account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Records of the calibration checks of automatic, mechanical or electronic equipment, including computers or related…
- 04
Deviations from written production and process control procedures are…
This inspection in context
Jose M. Cayuela
23 documents · 2012–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmHIKMA FARMACEUTICA (PORTUGAL), S.A history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at HIKMA FARMACEUTICA (PORTUGAL), S.A?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, production 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 HIKMA FARMACEUTICA (PORTUGAL), S.A?
Jose M. Cayuela is named on this Form 483, for the inspection of Apr 13 – Apr 21, 2023. Each investigator has a profile showing what they cite most.
When was HIKMA FARMACEUTICA (PORTUGAL), S.A inspected by FDA?
The inspection ran Apr 13 – Apr 21, 2023, and the Form 483 is dated April 21, 2023.
How do I get the full Form 483 for HIKMA FARMACEUTICA (PORTUGAL), 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.