FDA Establishment Inspection Reports (EIRs) for SciAnda Pharmaceuticals – Inspections in 2015 and 2024, FEI: 3009853264, Changshu, Jiangsu, China.

FDA Establishment Inspection Reports (EIRs) for SciAnda Pharmaceuticals – Inspections in 2015 and 2024, FEI: 3009853264, Changshu, Jiangsu, China.

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Original Request: Establishment Inspection Reports for the inspections held in 2015 and 2024 at the following manufacturing facility: SciAnda (Changshu) Pharmaceuticals, Ltd. No. 16 Dongzhou Road Economic Development Zone Changshu, Jiangsu, 215513 China (FEI No. 3009853264) Dates of Inspections: October 26 – 30, 2015 (Inspection ID: 951273) and March 25 – March 29, 2024 (Inspection ID: 1237197) Inspection Type: Human Drug
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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