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Supplier Quality Management
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| I observed on 11/18/2024 an alert message displayed on HPLC ID #QC-400 Dr. Reddy's Laboratories Limited (Unit II) |
19 Nov 2024 | Normal | Justification: Quality agreements are not being enforced, leading to potential quality issues with supplied water. Excerpt: Quality Agreements...suppliers are responsible to ensure pH of the (b) (4) water. View 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 highlights the need to establish the reliability of the supplier's analyses. Excerpt: establishing the reliability of the supplier's analyses through appropriate validation of the supplier’s test results at appropriate intervals. View Details |
| Establishment of the reliability of the component supplier's report of analyses is deficient Nubratori, Inc |
26 Jul 2024 | Normal | Justification: The observation directly pertains to the process of ensuring supplier quality, as it involves qualification and validation of the supplier's test results. Excerpt: Your firm has not performed full testing of incoming raw materials from its BDS supplier, since 2019. 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: Observations indicate a lack of robust supplier quality management, with dependency on supplier-provided data sans verification. Excerpt: Your firm does not test these products for (b) (4) contamination. For example, (b) (4) lots of (b) (4) received since March 1, 2022 was not tested for (U) (4) contamination but used in the production of non-sterile and sterile grade (b) (4) API. View Details |
| There are deficiencies in testing for the incoming components. Resilience USA, Inc. |
16 Feb 2024 | Normal | Justification: The reliance on potentially unverified supplier certificates impacts material quality management. 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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