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Pest Control
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| Buildings used in the manufacture, processing, packing or holding of drug products are not free of infestation by rodents, birds insects, and other vermin. ProRx LLC |
02 Aug 2024 | Normal | Justification: The observation explicitly states that the firm lacks a pest control program leading to the infestation. Excerpt: Specifically, your firm does not have an established pest control program. View Details |
| There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. Catalent Indiana, LLC |
15 Nov 2023 | Normal | Justification: The observation involves a specific event where a pest was found, indicating a lapse in pest control measures. Excerpt: REC 723587...the discovery of a pest inside (b) (4) System (b) (4) (Syringe Line on 14 JUN 2023. View Details |
| There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications Catalent Indiana, LLC |
15 Nov 2023 | Normal | Justification: The observation includes a specific instance of pest detection, highlighting potential weaknesses in the pest control process. Excerpt: Pest found in (b) (4) System (b) (4) Room 880 View Details |
| Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition and free of infestation Central Admixture Pharmacy Services, Inc. |
31 Jul 2023 | Normal | Justification: Pest control is crucial to ensure drug product manufacturing areas are free from infestation and contamination, which is directly tied to the observation. Excerpt: a deceased...lizard in ISO 7 cleanroom... View Details |
| Vermin was observed in the production area. Burt’s Pharmacy LLC |
23 May 2023 | Normal | Justification: The observation highlights a failure in pest control processes as evidenced by the presence of a spider in the production area. Excerpt: a live spider was observed crawling on the counter and sink in the hazardous production room. View Details |
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