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Batch Records
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements OSRX Inc. |
25 Oct 2024 | Normal | Justification: The issue directly relates to the integrity and completeness of batch records prior to product release. Excerpt: your firm performed an early release of drug product...without the sterility testing being completed... View Details |
| The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing, processing, and packing. Biocon Sdn Bhd |
27 Sep 2024 | Normal | Justification: Batch Records are linked to the observation due to missing documentation of essential production steps, critical for traceability. Excerpt: Batch records do not include documentation of the accomplishment of each significant step. No system to link finger dab results. View Details |
| Records associated with the API distribution were not readily available Aarti Drugs Limited |
20 Sep 2024 | Normal | Justification: Missing batch numbers and overlooked suffixes demonstrate flawed batch record maintenance and control. Excerpt: The corresponding Batch No. (Mfg. date (b) (4) June 2022 Expiry date was missing from the initial list submitted. View Details |
| There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications. Granules India Limited |
06 Sep 2024 | Normal | Justification: Observation highlights discrepancies in batch handling and documentation, falling under the batch records process. Excerpt: Your firm dispatched the failing batch # (3rd PV batch) along with batches # 1st PV (b) (4) (b). View Details |
| There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch Annovex Pharma, Inc. |
06 Sep 2024 | Normal | Justification: Batch Records process is pivotal as discrepancies in batch records directly impact product quality. Excerpt: the failure of a batch or any of its components to meet any of its specifications. View Details |
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