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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 |
|---|---|---|---|
| Written procedures are not followed for the receipt, storage and handling. Bausch and Lomb Incorporated |
20 Mar 2026 | Normal | Justification: Incorrect placement of materials in storage highlights deficiencies in material control protocols. Excerpt: Materials not placed in specified locations as per inventory management system. View Details |
| You did not review production records to determine whether errors had occurred. Isorx Cyclotron Center |
13 Mar 2026 | Normal | Justification: The observation pertains to the mismanagement and erroneous use of expired materials, fundamental to material storage and control. Excerpt: The firm lacks an effective material management and inventory tracking system to prevent mix-ups of expired materials. View Details |
| b. (b) (4) was observed with Hospira, Inc. |
10 Mar 2026 | Normal | Justification: The observation indicates frequent leaks from material lines, directly associated with material handling and control. Excerpt: b. (b) (4) line to an open bucket, along with locations. View Details |
| You did not ensure that establishment(s) that by contract, agreement or arrangement, perform manufacturing steps for you were in compliance with applicable CGTP requirements prior to the initiation IsoTis OrthoBiologics, Inc. |
06 Mar 2026 | Normal | Justification: Material Storage and Control is directly impacted as improper temperature management was identified. Excerpt: Your firm failed to require at least (b) (4) of your consignees to maintain, record, and periodically review storage temperature records. View Details |
| All compounding and storage containers used during the production of a batch of drug product is not properly identified Accra-Pac, Inc. |
05 Mar 2026 | Normal | Justification: Material Storage and Control is crucial in preventing mix-ups and ensuring traceability within the manufacturing process. Excerpt: The tankers displayed only tank numbers and lacked labels or placards indicating their receiving status and contents. View Details |
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