Glossary
Field Alert Report (FAR)
A report that must reach FDA within 3 working days when a distributed medicine is found to have labelling confusion, bacterial contamination, deterioration, or a specification failure.
Details
This is a United States specific reporting duty that falls only on the application holder, and the 3 working day clock from receipt of the information runs regardless of whether a recall follows. It covers two branches: incidents in which the product or its labelling could be mistaken for another, and bacterial contamination, a significant chemical or physical change, or a distributed batch failing specification. The corpus repeatedly shows information about bacterial contamination received but no report filed within the deadline, so check the date the complaint or test result was known, the date the report was filed, and what was done in between.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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The evidence gathered during the inspection shows that Vetos-Farma as the MIA holder purchases from APIs importers streptomycin sulphate, which should be used in the manufacture of the veterinary medicinal product Strepto 37.5; powder for solution for pigs.
EMA · EU GMP NCR (EudraGMDP) · 2024-09-23 -
The competent authority of Berlin decided to recall the only batch from the market that was imported so far from the Berlin importer.
EMA · EU GMP NCR (EudraGMDP) · 2025-09-11 -
not treating animal patients, could entail more risk to public and animal health, animal welfare, and animal survival, compared to allowing products for treatment which were produced under the non-compliance findings.
EMA · EU GMP NCR (EudraGMDP) · 2026-04-21
