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Training Management
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| Appropriate controls are not exercised over computers or related systems to assure... Dr. Reddy's Laboratories Limited (Unit II) |
19 Nov 2024 | Normal | Justification: Employees' inability to perform basic operations indicates insufficient training and knowledge transfer on software use. Excerpt: You have not trained your personnel on their operations (i.e. Empower 3.6.1...) View Details |
| Your firm failed to establish adequate written procedures for production and process controls Biocon Sdn Bhd |
27 Sep 2024 | Normal | Justification: Observation highlights the gap in operator training specifically related to SOP training for end filling operations. Excerpt: Operators are neither trained nor provided instructions in the SOP for filling machine operations. View Details |
| Responsibilities and procedures for quality units are not in writing and/or followed to ensure the API and intermediates manufactured... Aarti Drugs Limited |
20 Sep 2024 | Normal | Justification: The observation of repeat training requirements for similar issues demonstrates a flaw in the training management system. Excerpt: Activities at the facility are inadequately completed despite training given. Several personnel retrained on the same topic... View Details |
| Written procedures are not followed that describe the in-process controls to be conducted on appropriate samples of in-process materials of each batch. Granules India Limited |
06 Sep 2024 | Normal | Justification: Improper execution of procedures indicates deficiencies in training management and understanding of SOPs. Excerpt: Your operator verbally confirmed that they did not count the tablets nor did they look at both sides. View Details |
| Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination Zydus Lifesciences Limited |
29 Aug 2024 | Normal | Justification: Effective training is fundamental to ensuring that operators adhere to critical aseptic protocols, preventing contamination. Excerpt: operators touched (b)(4) stoppers with the (b)(4) restricted access barrier system View Details |
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