Import Surveillance and Detention Process for Condoms Failing Water Leak Testing Requirements
This guidance outlines FDA's strategy for surveillance and detention of imported condoms that fail to meet quality requirements, particularly water leak testing criteria. It establishes a three-level risk-based detention process for managing imports from manufacturers/shippers whose condoms have failed FDA's minimum acceptable quality criteria.
What You Need to Know? 👇
What is the legal basis for FDA to refuse admission of condoms into the United States?
FDA may refuse admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act if condoms appear adulterated or misbranded. Additionally, section 801(a)(1) allows refusal when manufacturing methods don’t conform to Quality Systems regulation requirements under section 520(f).
How does the three-level detention system work for condom imports?
The system escalates based on violation history: Level 1 requires 5 consecutive passing shipments for removal, Level 2 requires 10 consecutive passing shipments, and Level 3 involves systemic manufacturing issues requiring FDA inspection or third-party audit for compliance demonstration.
What evidence can manufacturers provide to release individual shipments during detention?
Manufacturers can present independent private laboratory testing results from qualified U.S. laboratories using FDA’s sampling plans and test methods. Testing must follow CPG 7124.21 requirements and demonstrate the specific shipment meets FDA’s acceptable quality criteria.
How long does an Import Surveillance Cycle last for condom manufacturers?
An Import Surveillance Cycle begins when a manufacturer is placed on Level 1 detention and ends after 24 months, unless the manufacturer advances to Level 3 detention. The cycle can also end early upon successful removal from interim status.
What happens when condoms are placed on Import Alert #85-02 Attachment B?
Placement on Attachment B indicates appearance of non-conformance with Quality Systems regulation. Future shipments may be refused under section 801(a)(1) until manufacturers provide adequate evidence through FDA inspection or qualified third-party audit demonstrating compliance.
Can manufacturers request reconsideration if they believe their detention level is inappropriate?
Yes, manufacturers can submit evidence to CDRH to rebut inappropriate Level 2 or Level 3 placement. Examples include demonstrating type 1 sampling errors or proving previous violations occurred during a concluded cycle, warranting only Level 1 detention.
What You Need to Do 👇
Recommended Actions
- Implement water leak testing according to CPG 7124.21 requirements
- Establish process for proper sampling across different condom styles and cartons
- Maintain records of import history and detention levels for each manufacturer
- For detained shipments:
- Level 1: Submit 5 consecutive passing private lab test results
- Level 2: Submit 10 consecutive passing private lab test results
- Level 3: Demonstrate Quality System compliance through inspection/audit
- Review manufacturing procedures and practices if placed on detention
- Maintain documentation of all test results and corrective actions
- Submit proper documentation to FDA for removal from import alert when requirements are met
- Consider third-party audits to verify Quality System compliance if needed
Key Considerations
Non-clinical testing
- Water leak testing according to CPG 7124.21 sampling and testing requirements
- Testing by independent private laboratories in the US for release of detained shipments
- Multiple styles should not be mixed in one sample
- Representative sampling from several cartons required
Safety
- Condom defects like holes can compromise barrier effectiveness and pose significant health hazards
- One violative sample may be sufficient for detention due to potential health hazard
Other considerations
- Three-level detention process based on manufacturer’s import history
- Level 1: First violation - requires 5 consecutive passing shipments for removal
- Level 2: Second violation - requires 10 consecutive passing shipments for removal
- Level 3: Third violation - requires facility inspection/audit and quality system compliance
- 24-month surveillance cycle unless Level 3 detention occurs
- Quality System regulation compliance required for Level 3 removal
Relevant Guidances 🔗
- Medical Gloves - Premarket Notification, Quality System, Labeling and Compliance Requirements
- Testing Requirements for Metallic Plasma Sprayed Coatings on Orthopedic Implants
- Postmarket Surveillance Studies Requirements for Medical Devices Under Section 522
Related references and norms 📂
- 21 CFR Part 820: Quality System Regulation