Import Alert Guide
Import Alert 66-40 — Drugs, GMP
A plain-language guide to FDA Import Alert 66-40, which allows detention without physical examination of drugs from firms that have not met drug GMPs. What it covers, why it works differently from a contaminant alert, and what clearing it actually requires.
The Short Version
What Is Import Alert 66-40?
Import Alert 66-40 permits FDA to detain, without physical examination, drugs from firms whose manufacturing does not conform to current good manufacturing practice (CGMP). Like the dietary-supplement GMP alert, this one is about the manufacturing system: when an FDA inspection finds a drug manufacturer isn't operating in conformity with CGMP, FDA can treat the firm's drug products as adulterated — not because a specific lot failed a test, but because the methods and controls used to make them don't meet the standard. Listings commonly reach all drug products tied to the firm as manufacturer or shipper.
- Alert Number
- 66-40
- Products Covered
- Drugs and drug products from Red List firms — often all such products tied to the listed manufacturer or shipper
- Charge
- Adulteration — methods and controls do not conform to CGMP (Section 501(a)(2)(B); OASIS DRUG GMPS)
- Basis for Listing
- FDA foreign inspection (or a recognized foreign-authority inspection) finding non-conformity with CGMP
- Reviewing Center
- CDER for human drugs; CVM for animal drugs
- Official Text
- FDA Import Alert 66-40
The Background
Why 66-40 Works Differently From a Contaminant Alert
Drug CGMP requirements exist so that a drug's identity, strength, quality, and purity can be relied upon. FDA inspects pharmaceutical manufacturers — including foreign ones — to verify compliance, and may also act on inspections conducted by foreign or other government authorities under a Memorandum of Understanding or similar agreement.
When an inspection reveals a firm isn't operating in conformity with CGMP, FDA's concern is the manufacturing system, not a single batch. On that basis, FDA can place the firm on 66-40, and detention can reach the firm's drug products broadly — in many listings, all drug products where the firm is named as manufacturer or as shipper. Detention remains in effect until FDA is satisfied the appearance of the violation has been removed.
This is the crucial difference: a contaminant detention can often be answered by testing the specific lot. A drug-GMP detention usually cannot — a clean test on one shipment does not demonstrate that the firm's methods and controls now conform to CGMP.
The Evidence
What Clearing a 66-40 Listing Typically Involves
Because the issue is the manufacturing system, the path centers on correcting and documenting CGMP compliance to the satisfaction of the responsible FDA Center — usually confirmed by reinspection. Testing plays a supporting role, not the lead one.
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Correct the CGMP Deficiencies
The firm addresses the specific CGMP findings FDA cited — methods, facilities, controls, and quality systems — and documents the corrective actions. This is regulatory and operational work, typically led by the firm's CGMP or regulatory consultant or counsel.
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Document to the FDA Center
A removal request demonstrates the conditions giving rise to the violation were resolved, submitted to the responsible Center (CDER for human drugs, CVM for animal drugs). Analytical testing of product can support the picture but supports the CGMP case rather than replacing it.
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FDA Gains Confidence
FDA must be satisfied future shipments will comply — often confirmed by reinspecting the facility or reviewing appropriate documentation. FDA makes the final decision on removal and on the admissibility of any individual entry.
Where testing fits. We coordinate sampling and independent laboratory analysis that can support a CGMP corrective-action file — for example, verifying a product's identity, strength, quality, and purity. That evidence can strengthen a removal package, but the core of a 66-40 case is CGMP remediation and FDA's confidence in the facility, usually led by your CGMP or regulatory consultant or counsel. See our laboratory testing coordination guide.
Be Realistic
What This Alert Means in Practice
Honest limitations
- Testing alone usually won't clear it. This is a manufacturing-system alert. A clean result on one shipment does not show the firm's methods and controls now conform to CGMP, so lab testing rarely resolves a 66-40 listing by itself.
- It's broad by design. Listings often reach all drug products where the firm is named as manufacturer or shipper — not just one product line.
- Removal can require reinspection. Detention remains until FDA is satisfied the violation's appearance is removed, frequently confirmed by reinspecting the facility, which can make the timeline longer than a contaminant case.
- CGMP remediation is the real work. The center of gravity is correcting and documenting the manufacturing system to the responsible FDA Center — sampling and testing support that effort rather than substitute for it.
Related
Related Alerts & Guides
Dietary Supplements — GMP
The supplement-side GMP alert — the same manufacturing-system logic applied to dietary supplements.
Read the guide IA 53-06Cosmetics — Color Additive Violations
A cosmetics alert — color additive adulteration and misbranding rather than manufacturing practice.
Read the guide IndustryPharmaceutical Testing Support
Category overview: how sampling and testing support drug importers facing detention.
View industriesDrugs Detained Under 66-40?
Bring Us the Notice — We'll Tell You Honestly Where Testing Helps
Send your FDA Notice of Action and product details. You'll get a straight read on the CGMP nature of this alert and where independent testing can genuinely support a corrective-action file — and where it can't — before any commitment.
Urgent detention matters receive priority intake review.
FDA Detention Sampling is an independent private company. We are not affiliated with, endorsed by, or part of the U.S. Food and Drug Administration. This guide is a plain-language summary of Import Alert 66-40; the official alert text published by FDA is authoritative and controls. Sampling, laboratory testing, documentation, and coordination services do not guarantee FDA release, admissibility, acceptance of laboratory results, removal from any import alert, or any specific regulatory outcome. CGMP remediation and petitions for removal are regulatory matters typically led by a firm's CGMP or regulatory consultant or attorney. FDA makes the final admissibility decision.