Act as a USFDA investigation writer with 20 years ...
创建于：2026年8月1日
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问题
executed BPR.pdf
Initial Assesment.docx
dispensing sheet.pdf
Dispensing label.pdf
Act as a USFDA investigation writer with 20 years of experience in this field and Prepare the initial assessment of the deviation properly. reference documents are provided. DEVIATION REPORTING DETAILS
Short Description:
Unprinted shipper found instead of printed shipper at Shipper No. 45 of 70 during secondary packing of Felvin 20 mg Capsules, Batch 0360190A.
Description of Deviation:
On dated 01/08/2026 at 10:00 hrs., during the secondary packing operation of product Felvin 20 mg Capsules, Batch No. 0360190A, Packing Officer Mr. Jay Dhiver (Emp. ID: 10001944) identified that, while packing of Shipper No. 45 out of 70, the shipper was unprinted/laminated instead of the required printed shipper.
5W & 2H Answer
What? (What is the problem) During secondary packing, an unprinted/laminated shipper was identified while packing Shipper No. 45 out of 70 for Felvin 20 mg Capsules, Batch No. 0360190A.
Which? (In which line/which batch/which product) Product: Felvin 20 mg Capsules, Batch No. 0360190A, Shipper No. 45 out of 70.
Where? (Where is the problem identified) Secondary packing area (Room No. GF-52)
When? (Date/Time of identification of problem) On dated 01/08/2026 at 10:00 hrs.
Who?? (Who has identified the problem) Packing Officer Mr. Jay Dhiver (Emp. ID: 10001944)
How? (How was problem identified) During the routine secondary packing operation, while packing Shipper No. 45 out of 70, the packing officer visually identified that the shipper did not bear the required printing.and SOP/PG/096) had not been completed within the TCD of 28/02/2026.
How many? (How many batches) One Batch, Batch No. 0360190A.
26 shippers are with another sap batch number which having the unprinted.
思考
回答
Completed Initial Assessment
The revised report includes:
- Chronological packing timeline and detection at Shipper No. 45.
- Calculation that 44 completed full shippers represent 6,600 inner cartons, subject to final BPR reconciliation.
- Detailed comparison of printed and unprinted shippers, including material code, dimensions, SAP batches, quantities, bin locations, printing and physical appearance.
- Traceability assessment linking the first 44 shippers to SAP batch 1000139291 and the 26 suspect shippers to SAP batch S2603427.
- Preliminary impact assessment, deviation classification, containment controls, investigation scope and recommended actions.
- Clear distinction between documented actions and actions requiring confirmation, so unsupported activities are not recorded as completed.
The assessment was developed from the event description and proposed actions in the supplied template, (Initial Assesment.docx) (Initial Assesment.docx) the executed BPR packing configuration and sequence records, (executed BPR.pdf) and the dispensing sheet and labels showing the 44/26 material-lot split. (dispensing sheet.pdf) (Dispensing label.pdf)
The regulatory framing addresses FDA expectations for packaging-material examination, strict labeling control, prevention of packaging/labeling mix-ups and thorough discrepancy investigations under 21 CFR 211.122, 211.125, 211.130 and 211.192. (U.S. Food and Drug Administration)