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Area Cleaning
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: Dirty AHU vents directly relate to inadequate area cleaning practices, essential for compliance. Excerpt: AHU Vents were observed dirty, impacting production areas. View Details |
| Contamination was observed in your production area and areas adjacent to production areas Avenue Pharmacy Inc dba Pathway Pharmacy |
04 Oct 2024 | Normal | Justification: Area Cleaning is relevant due to the observation of unclean surfaces and visible contaminants in critical areas. Excerpt: White powder residue was observed on ALL surfaces (refrigerator, countertops, Bulk Drug Substance containers, etc.). View Details |
| Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. RC Outsourcing, LLC |
27 Sep 2024 | Normal | Justification: Critical area cleaning is essential for sterility; without thorough protocols, contamination risks increase. Excerpt: Operators failed to clean wires used to connect UV lights near the ceiling inside the ISO 5 LAFW. View Details |
| Written procedures are not established for cleaning of equipment and its subsequent release for use Aarti Drugs Limited |
20 Sep 2024 | Normal | Justification: Area Cleaning involves ensuring that post-cleaning, equipment is properly validated for cleanliness for the next use. Excerpt: Written procedures are not established for cleaning of equipment and its subsequent release for use. View Details |
| Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. Nubratori, Inc |
26 Jul 2024 | Normal | Justification: Observation indicates critical lapses in the cleaning of areas meant to maintain aseptic conditions. Excerpt: I observed that the operator failed to wipe down the ISO 7 side View Details |
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