Oct 5 to Oct 11, 2026
What FDA published for drug, device and biologics teams: 5 warning letters, 8 OAI inspections.
Warning letters 5
Eurofins SF Analytical Laboratories, Inc.
Pro-Optics LLC
Silgan Unicep Packaging, LLC.
SCA Pharmaceuticals, Inc.
Inspections classified Official Action Indicated 8
Fuller Industries IncOAI
Medline Industries, LPOAI
Endovascular Engineering, IncOAI
Aspen SA Sterile Operations (Pty) Ltd.OAI
LeMaitre Vascular, Inc.OAI
Pro-Optics LLCOAI
Gyrus ACMI, Inc.OAI
SCA Pharmaceuticals, Inc.OAI
Ask the same questions against your own records
Arca reads FDA's enforcement history the way this issue was written, and reads it against your deviations, CAPAs and submissions, so a failure mode you are investigating comes back with the precedent attached and cited to the record.
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