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Process Control
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| Written production and process control procedures are not followed in the execution of production and process control functions. RC Outsourcing, LLC |
27 Sep 2024 | Normal | Justification: The visual inspection process is key to ensuring product quality under 'Process Control' as specified in the SOP. Excerpt: The visual inspection operators did not follow the syringes for visual inspection as required by SOP-43. View Details |
| Your firm failed to establish adequate written procedures for production and process controls Biocon Sdn Bhd |
27 Sep 2024 | Normal | Justification: The observation reveals lacking SOP adequacy and review in process controls, vital for maintaining drug identity, strength, purity, and quality. Excerpt: Sterile glove leak test procedure is inadequately written; post-integrity reports were not reviewed by Quality. View Details |
| Your firm failed to establish adequate written procedures for production and process controls Brookfield Medical Surgical Supply, Inc. |
27 Sep 2024 | Normal | Justification: The observation specifically mentions the failure to establish adequate written procedures for production and process controls, directly linked to 'Process Control.' Excerpt: Your firm failed to establish adequate written procedures for production and process controls. View Details |
| Written procedures are not followed that describe the in-process controls Granules India Limited |
06 Sep 2024 | Normal | Justification: The issue is directly linked to the inadequate execution of process control procedures, impacting batch integrity. Excerpt: Written procedures are not followed that describe the in-process controls to be conducted. View Details |
| The process of material from the commonly performed Granules India Limited |
06 Sep 2024 | Normal | Justification: Process Control is linked due to inadequate assessment and validation of collected material before further processing. Excerpt: There has been no documented scientific evidence that the material ... meets the minimum ... in-process check. View Details |
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