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Calibration Management
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: Expired calibration references indicate insufficient control over calibration practices, risking data veracity. Excerpt: Utilized (b) (4) Lot # (b) (4) with (b) (4) expiry date from 09/30/2024 to calibrate. View Details |
| Equipment used in the manufacture, processing, packing or holding of drug products are not maintained in a manner to prevent malfunctions that would alter the drug product quality. Biocon Biologics Limited |
26 Jul 2024 | Normal | Justification: Preventive maintenance records missing tracer information for instruments used in verification processes implicate weaknesses in calibration management. Excerpt: Preventive maintenance records... do not identify the instruments used for verifying laminar flow and pressures. View Details |
| Investigations of an unexplained discrepancy or a failure to meet a specification were not thorough Biocon Biologics Limited |
26 Jul 2024 | Normal | Justification: Discrepancies in calibration data and lack of oversight directly implicate calibration management processes. Excerpt: The investigation found the calibration records generated by a third party vendor did not report accurate data... View Details |
| Input to and output from the computer and records or data are not checked for accuracy. Eugia Steriles Private Limited |
05 Apr 2024 | Normal | Justification: Calibration management is directly impacted by the observed discrepancies in the calibration certificates and the tools and methods used. Excerpt: Calibration certificates issued on Monday April 1, 2024 ... provide a direct reading of however the service employee (b) (4) 02 ... calculation and use of equipment 02 was not documented or noted in the calibration certificate. View Details |
| Routine calibration of automatic, mechanical and electronic equipment is not performed according to a written program Qualgen, LLC |
19 Mar 2024 | Normal | Justification: Calibration Management is directly linked as the observation describes a failure in bracketing the calibration range for key equipment. Excerpt: Specifically, Your firm is not bracketing the range of use when calibrating all equipment used in the manufacture of hormone pellets. View Details |
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