# China NMPA Inspection - Shandong Bausch & Lomb Freda Pharmaceutical Co., Ltd. - June 07, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/shandong-bausch-lomb-freda-pharmaceutical-co-ltd/2d5162e9-8b56-4c1f-a0c4-332d4cecc2c7/
Source feed: China

> China NMPA unannounced inspection for Shandong Bausch & Lomb Freda Pharmaceutical Co., Ltd. published June 07, 2018. An unannounced inspection of Shandong Bausch & Lomb Freda Pharmaceutical Co., Ltd. was conducted from May 22-23, 2018. The inspection, based on Good M

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Shandong Bausch & Lomb Freda Pharmaceutical Co., Ltd.
- Company Name: Shandong Bausch & Lomb Freda Pharmaceutical Co., Ltd.
- Publication Date: 2018-06-07
- Product Type: Device
- Summary: An unannounced inspection of Shandong Bausch & Lomb Freda Pharmaceutical Co., Ltd. was conducted from May 22-23, 2018. The inspection, based on Good Manufacturing Practices (GMP) for Medical Devices, particularly those for sterile products, identified eight general deficiencies. Key issues included improper storage practices where materials requiring sterilization and analysis were commingled with other items in an automated warehouse, and inadequate record-keeping for environmental monitoring sample handling and equipment cleaning. The company also failed to adhere to its own protocols for ethylene oxide residue testing timelines and could not demonstrate control over residue levels. Furthermore, there was an inconsistency between validation and practice for compressed air filter replacement, and customer complaint investigations for product air bubbles concluded "no product quality defects" without evident deeper analysis. Regulatory authorities have ordered Shandong Bausch & Lomb Freda Pharmaceutical Co., Ltd. to promptly rectify these deficiencies and assess product safety risks. Should safety hazards be identified, the company must initiate product recalls. Follow-up inspections may occur, and rectification reports must be submitted to the National Medical Products Administration.

Company: https://www.globalkeysolutions.net/companies/shandong-bausch-lomb-freda-pharmaceutical-co-ltd/cf462634-e0a2-443e-8eda-0da97bc9fc9f/