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Water Quality Monitoring
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: Failure to obtain and check water quality documentation leads to uncontrolled quality risks. Excerpt: suppliers did not provide you with any documentation not limited to certificate of analyses. View Details |
| The routine sample volume that is used to test for appropriate standards of quality Novo Nordisk A/S |
25 Mar 2024 | Normal | Justification: Observation points to insufficient sample volumes for water quality, directly relating to water quality monitoring. Excerpt: The routine sample volume ... is insufficient to be representative of the capacity of the water systems. View Details |
| Insufficient information has been provided to demonstrate that the water and water used for Novo Nordisk A/S |
25 Mar 2024 | Normal | Justification: The issue of microbial contamination directly relates to the adequacy of Water Quality Monitoring processes. Excerpt: water used for drug substance (DS) purification is adequately controlled for total microbial counts. View Details |
| The plumbing system contains defects that could contribute to the contamination of drug products. Shilpa Medicare Limited |
09 Nov 2023 | Normal | Justification: The observation clearly indicates issues with the water quality monitoring system, directly related to the absence of continuous sanitization and the existence of dead legs. Excerpt: Your (b) (4) water and water (b) (4) loop do not have a step for continuous sanitization. View Details |
| The (b) (4) system contains defects that could contribute to the contamination of drug products. Aqualex Co., Ltd. |
20 Oct 2023 | Normal | Justification: Water samples exceeding microbial limits indicate issues with routine water monitoring protocols. Excerpt: Results exceeding your limit of (b) (4) cfu/mL were identified, but not addressed. View Details |
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