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Explore essential insights on batch release processes to enhance compliance and quality. Dive into our article for practical guidance and best practices.

| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| Commitment to Quality in Pharmaceutical Development Not available |
29 Jun 2026 | Normal | Justification: Quality risk management is essential for the development program to prevent defects, errors, and ensure continual improvement. Excerpt: Evaluate the pharmaceutical development program to determine the following: Resources are provided to perform activities... View Details |
| Readiness for Commercial Manufacturing Not available |
29 Jun 2026 | Normal | Justification: Quality Risk Management is crucial for ensuring that a control strategy can mitigate potential issues in manufacturing. Excerpt: Determine whether the establishment has a quality system designed to achieve sufficient control. View Details |
| Copies of Approved or Indexed Products: Mixlab WI LLC |
01 May 2026 | Normal | Justification: This observation involves inadequate risk assessment and management practices, specifically with regards to ensuring the necessity and safety of compounded drugs. Excerpt: Your records did not include the reasons why this prescription was compounded from BDS as opposed to using an FDA-approved product as the source of the active ingredient(s). View Details |
| Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations. Bora Pharmaceuticals Injectables Inc |
20 Mar 2026 | Normal | Justification: Risk assessments play a crucial role in identifying and controlling contamination risks in shared manufacturing environments. Excerpt: Risk assessments failed to identify and evaluate potential cross-contamination risks... no adequate justification for multi-product strategy. View Details |
| The responsibilities and procedures applicable to the quality control unit are not fully followed. Eosera, Inc. |
20 Mar 2026 | Normal | Justification: The failure to reject defective lots and lacking stability study documentation indicates lapses in quality risk management. Excerpt: Your firm failed to reject lot #(b) (4) and documentation addressing the cessation of the long term stability study for this lot. View Details |
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