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Environmental Monitoring
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| Buildings used in the manufacturing of Intermediates and finished APIs are not maintained in a good state of repair. Dr. Reddy's Laboratories Limited (Unit II) |
19 Nov 2024 | Normal | Justification: The presence of flying insects indicates a breach in environmental controls affecting product safety. Excerpt: I observed presence of flying insects during my inspectional walkthrough of (b) Block. View Details |
| Aseptic processing areas are deficient regarding the system for monitoring environmental conditions OSRX Inc. |
25 Oct 2024 | Normal | Justification: The observation directly cites deficiencies in environmental monitoring practices of aseptic processing areas, requiring revised protocols. Excerpt: Specifically, A) There are no ISO 5 viable surface samples taken during the earlier lots being manufactured. View Details |
| Your firm failed to appropriately clean equipment located in the ISO 5 area. Brookfield Medical Surgical Supply, Inc. |
27 Sep 2024 | Normal | Justification: Link to Environmental Monitoring due to the failure in acting on excursion data. Excerpt: Your firm failed to perform a (b) (4) clean when environmental monitoring excursions involve objectionable organisms... View Details |
| Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness and compliance with established standards. RC Outsourcing, LLC |
27 Sep 2024 | Normal | Justification: The effectiveness of environmental monitoring is dependent on accurate and verified data to ensure contamination control. Excerpt: Results are recorded in an Excel sheet. However, the raw EM data can be altered in the Excel sheet. View Details |
| Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed. RC Outsourcing, LLC |
27 Sep 2024 | Normal | Justification: Adequate environmental monitoring is necessary for maintaining aseptic conditions, as deficiencies were noted in gowns and non-viable monitoring. Excerpt: The EM monitoring of non-viable particles and active air sampling are inadequate. View Details |
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