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{
"alert_number": "66-40",
"alert_name": "Detention Without Physical Examination of Drugs From Firms Not Operating in Conformity With CGMP",
"country": "China",
"industry_code": "54",
"issued_date": "2026-02-15",
"firms_listed": ["Jiangsu Nhwa Pharmaceutical Co Ltd"],
"products_affected": ["Azithromycin Dihydrate", "Fluconazole"],
"linked_apis": ["azithromycin_dihydrate", "fluconazole_api"],
"summary": "Firm failed to meet minimum CGMP requirements during distant site inspection.",
"source_url": "https://www.accessdata.fda.gov/cms_ia/importalert_189.html"
},
{
"alert_number": "99-32",
"alert_name": "Detention Without Physical Examination of Products from Firms on the Red List",
"country": "China",
"industry_code": "54",
"issued_date": "2025-11-20",
"firms_listed": ["Zhejiang Hisun Pharmaceutical Co Ltd"],
"products_affected": ["Atorvastatin Calcium", "Ciprofloxacin"],
"linked_apis": ["atorvastatin_calcium", "ciprofloxacin_hcl"],
"summary": "Continued inclusion on Red List due to persistent impurity issues in statin precursors.",
"source_url": "https://www.accessdata.fda.gov/cms_ia/importalert_99-32.html"
}
]
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