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 |
---|---|---|---|
Use of ingredients not intended for pharmaceutical use in sterile drug production Meds For Vets |
21 Feb 2025 | Normal | Justification: The observation highlights the use of non-pharmaceutical grade materials, indicating a failure in material control processes. Excerpt: The (b) (4) for irrigation used is labeled "not for injection". View Details |
01 not are used for storage, and of all during DS manufacturing Sanofi-Aventis Deutschland GmbH |
16 Jan 2025 | Normal | Justification: The observation highlights inadequate storage affecting product quality, emphasizing the need for stringent material control during storage. Excerpt: storage, and of all during DS manufacturing process. Although Step utilizes a less stringent generation process. View Details |
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the holding of rejected components, drug product containers, and closures before disposition. Exela Pharma Sciences LLC |
15 Nov 2024 | Normal | Justification: Proper material storage controls prevent contamination risks and ensure compliance with storage conditions for rejected materials. Excerpt: A red reject rectangular box labeled Sodium Chloride 0.9% was directly dripping (leaking) on a pallet with a Finished Product Inventory Log sheet placed on top. View Details |
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the receipt, identification, storage, and withholding from use of components, drug product containers, and closures pending sampling, testing, or examination by the quality control unit before release for manufacturing or packaging. Exela Pharma Sciences LLC |
15 Nov 2024 | Normal | Justification: Material storage directly impacts product stability. Failure to ensure proper refrigeration conditions risks quality deterioration. Excerpt: Manufacturer’s label on raw material indicates raw material API should be kept refrigerated at (b) (4). View Details |
Written procedures are lacking which describe in sufficient detail the storage of components, drug product containers and closures Annovex Pharma, Inc. |
06 Sep 2024 | Normal | Justification: Storage requirements are critical for material integrity. The observation indicates lapses in precisely documented procedures which are vital for 'Material Storage and Control'. Excerpt: Written procedures are lacking which describe in sufficient detail the storage of components, drug product containers and closures. View Details |
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