Form RDS

Release Determination Statement (RDS-)

Production Lot: Release Determination Statement Submission
Manufacturer Information
Manufacturer (FDA-FEI#)*
Check All Manufacturing Functions That Apply*

Measured/Compounded: Location where ingredients are measured, weighed, mixed and compounded.Sterilization: Location where product is sterilized.Vaccines: Location where vaccine is produced.Packaging: Location where intermediate containers will be fixed and labeled. (Primary Packaging and Serialization)Serialization: Location where barcode and DSCSA serialization occurs.Packing: Location where products will be packed and prepared for shipment.Print Components: Location where Print Components are prepared and printed.
Manufacturer POC Name*

First NameLast Name
Manufacturer POC Email*
Product Information
GENERIC NAME*
NDC11*
STRENGTH*
STRENGTH UNIT*
DOSAGE FORM*
PACKAGE TYPE*
Production Batch/Lot Information
LOT NUMBER*
LOT QUANTITY*
BATCH RECORD NUMBER (IF DIFFERENT)
MANUFACTURING DATE*

MonthDayYear
Date
Hour MinutesAM/PM Option
EXPIRATION DATE*

MonthDayYear
If N/A enter the same Manufacturing Date
Additional Information
File Submissions
BATCH RECORD*

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CERTIFICATE OF ANALYSIS (COA)*

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OTHER

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Release Determination Statement (RDS-)