# FDA 483 - Sinopep-Allsino Biopharmaceutical Co., Ltd. - September 20, 2024

Source: https://www.keypedia.com/records/483/sinopep-allsino-biopharmaceutical-co-ltd/41d3bebe-3aa8-48ea-99a0-9cdf5574b893

> FDA 483 for Sinopep-Allsino Biopharmaceutical Co., Ltd. on September 20, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sinopep-Allsino Biopharmaceutical Co., Ltd.
- Inspection Date: 2024-09-20
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: An FDA inspection of Sinopep-Allsino Biopharmaceutical Co., Ltd, an API manufacturer in Lianyungang, China, from September 12-20, 2024, revealed significant deviations from manufacturing standards, documented in a Form FDA 483. The primary issues identified involve critical aspects of quality control and facility management. First, major production equipment, including that used for US-bound APIs, was found to be inadequately cleaned. Inspectors observed API residue, metal particles, and a piece of a canvas glove on supposedly "clean" product-contact surfaces. The company's cleaning validation procedures were deficient, failing to evaluate critical areas, and standard operating procedures lacked specific instructions for all necessary cleaning steps. Second, the facility itself exhibited maintenance failures, specifically water leakage in areas designated for raw material storage and the microbiology laboratory. These incidents suggest a lack of routine upkeep and an inability to follow internal inspection procedures, as records were reportedly not maintained. Finally, pest control measures were insufficient. Inspectors found cobwebs, live, and dead insects in raw and auxiliary material storage areas, some near materials used for US market APIs. Furthermore, the design of warehouse and sampling room doors allowed for potential pest ingress, and existing pest control procedures did not ensure comprehensive area inspection. These observations indicate a need for Sinopep-Allsino to implement robust corrective and preventive actions, ensuring compliance with current Good Manufacturing Practices to safeguard product quality and patient safety.

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Company: https://www.keypedia.com/companies/sinopep-allsino-biopharmaceutical-co-ltd/f45b83cf-0416-4308-92bf-f7f3212ca356

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa