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| Requirement | Category | Deadline | Penalty | Reference |
|---|---|---|---|---|
| Annual registration | Mandatory | Dec 31 | $15,000 | 21 CFR 207 |
| Adverse event reporting | Mandatory | 15 days | Warning letter | 21 CFR 314 |
| Label review | Pre-market | Before launch | Seizure | 21 CFR 201 |
| GMP audit | Every 2 years | Ongoing | Import alert | 21 CFR 211 |
| Record keeping | Mandatory | Ongoing | $10,000/day | 21 CFR 211 |
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