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Sample Testing
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| You have not established Laboratory controls that include the establishment of scientifically sound and appropriate specifications Dr. Reddy's Laboratories Limited (Unit II) |
19 Nov 2024 | Normal | Justification: Observation underscores issues in sample testing and labeling, impacting QC sample traceability. Excerpt: Sample label does not include the source or location from where the sample was obtained. View Details |
| Your firm released drug product in which the strength differs from, or its purity or quality falls below, Avenue Pharmacy Inc dba Pathway Pharmacy |
04 Oct 2024 | Normal | Justification: Testing errors directly led to potency failures, necessitating a focus on enhancing sample testing accuracy. Excerpt: Your firm’s contract testing laboratory identified five potency failures... View Details |
| You assign the storage conditions and retest or expiry dates of the APIs using test procedures that are not stability indicating. Aarti Drugs Limited |
20 Sep 2024 | Normal | Justification: Ensures reliability and robustness in testing results crucial for maintaining product quality. Excerpt: Test procedures that are not stability indicating may lead to incorrect assessments of API quality. View Details |
| Your firm failed to establish adequate written procedures for production and process control designed to assure that drug products Zydus Lifesciences Limited |
29 Aug 2024 | Normal | Justification: Effective sample testing protocols are critical for accurate PPQ and ensuring intra- and inter-batch process consistency. Excerpt: Statistical sampling plans were not adequately established or followed for PPQ evaluations. View Details |
| Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing. Belcher Pharmaceuticals, LLC |
16 Aug 2024 | Normal | Justification: Improper testing methods can lead to undetected microorganisms, endangering product sterility and consumer safety. Excerpt: your firm's control testing lab utilizes the Sterility Testing Method (STM No. M109) which is inadequate... View Details |
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