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Material Sampling and Testing
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity ProRx LLC |
02 Aug 2024 | Normal | Justification: The observation directly mentions the lack of identity testing and validation of supplier's test results. Excerpt: without performing at least one specific identity test on each component and establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals. View Details |
| Each lot of a component liable to objectionable microbiological contamination is deficiently subjected to microbiological tests before use. Nubratori, Inc |
26 Jul 2024 | Normal | Justification: The observation highlights the failure to conduct necessary testing, directly associated with Material Sampling and Testing processes. Excerpt: Your firm failed to perform microbial and endotoxin testing on all lots of the following Bulk Drug Substances (BDS):... View Details |
| Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans Novo Nordisk A/S |
25 Mar 2024 | Normal | Justification: Material Sampling and Testing directly connect to the observation as the issue pertained to sample size inadequacy. Excerpt: A microliter sample is used to assess microbial contamination within a (b) (4) (b) (4) tank. View Details |
| Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications Otsuka Pharmaceutical Co., Ltd. |
22 Mar 2024 | Normal | Justification: The observation shows a clear gap in the process of material sampling and testing, where reliance on supplier certificates without internal verification led to non-compliance. Excerpt: Your firm maintains the certificate of analyses provided from your suppliers but failed to perform the identity test on at least (b) (4) lots received since 03/1/2022. View Details |
| There are deficiencies in testing for the incoming components. Resilience USA, Inc. |
16 Feb 2024 | Normal | Justification: Observation mentions testing deficiencies and lack of verification processes for supplier certificates, directly linking to this process type. Excerpt: The Firm has not established the reliability of the supplier's certificate of analysis through verification at appropriate intervals. View Details |
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