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Batch Release
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | 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: Releasing batches without proper quality checks directly impacts compliance and patient safety. Excerpt: Your firm released drug product in which the strength differs from, or its purity or quality falls below... View Details |
| There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications RC Outsourcing, LLC |
27 Sep 2024 | Normal | Justification: The batch release process directly affected, as it's reliant on comprehensive review and resolution of all specification failures. Excerpt: The batch was released after a reinspection showed passing results; however, no investigation has been conducted for this OOS result. View Details |
| Responsibilities and procedures for quality units are not in writing and/or followed to ensure the API and intermediates manufactured... Aarti Drugs Limited |
20 Sep 2024 | Normal | Justification: The shipping of non-compliant reworked batches highlights failure in controlling batch release processes. Excerpt: You shipped multiple batches of reworked APIs before completing the stability data... View Details |
| Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established Empower Pharmacy |
28 Aug 2024 | Normal | Justification: Batch Release process failure is highlighted as contaminated products were released without addressing known deviations. Excerpt: The batch was released and distributed to customers despite environmental monitoring and non-viable monitoring issues. View Details |
| Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. Belcher Pharmaceuticals, LLC |
16 Aug 2024 | Normal | Justification: Batch release process failed to ensure required impurity testing was completed before distribution. Excerpt: Testosterone Pellets, lot #(b) (4), were released for distribution without impurity testing. View Details |
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