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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 |
|---|---|---|---|
| Contamination was observed in your production area and areas adjacent to production areas. Veterinary Pharmacy Corporation |
19 Mar 2026 | Normal | Justification: Penicillin Contamination issues are indicated by uncleaned equipment and lack of garbing protocols. Excerpt: Your firm does not have written procedures regarding personnel movement or garbing changes between Amoxicillin and non-Amoxicillin production areas. View Details |
| Beta-lactam drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination East Orange VA Medical Center |
29 Apr 2025 | Normal | Justification: Directly relates to the handling of penicillin, requiring specific measures to prevent contamination as noted in the observation text. Excerpt: Your firm does not have policies in place to deactivate Penicillin and Beta Lactam products after production. View Details |
| Your firm failed to perform operations related to the Manufacture, processing and packing of (b) (4) in facilities Zhejiang Jinhua Conba 310-Pharm. Co. Ltd |
01 Aug 2023 | Normal | Justification: Manufacturing operations related to drug products must be conducted in separate areas to prevent penicillin contamination. Excerpt: Your firm failed to perform operations...in facilities separate from those used for other drug products for human use. View Details |
| The flow of components and drug products through the building is not designed to prevent contamination. Eurovet Animal Health B.V. |
25 Oct 2022 | Normal | Justification: Penicillin contamination is directly linked due to inadequate segregation and decontamination measures leading to cross-contamination. Excerpt: Penicillin and non-penicillin raw materials are received at a common receiving location in the warehouse. View Details |
| Records are not kept for the cleaning of equipment Eurovet Animal Health B.V. |
25 Oct 2022 | Normal | Justification: Penicillin contamination control is crucial due to the omission of corrective action records for penicillin excursions. Excerpt: No records of cleaning performed as a corrective action following Penicillin excursions in the sterile area. View Details |
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