This link from Lonza …..a bit of PR but it tells you what the FDA has done…my bolding
….
Quality systems and regulatory inspections
We operate local quality management systems that comply with internal policies as well as with national and international standards and regulations (e.g. GMP, PIC/S)
We are proud of our excellent track record of over 20 successful inspections from various agencies over the past seven year without any critical observations.
- United States Food and Drug Administration (US FDA) Code of Federal Regulations (CFR) Title 21, Parts: 11, 210, 211 and 600 (where applicable)
- Eudralex - Volume 4 Good Manufacturing Practice (GMP) Guidelines
- International Council for Harmonization (ICH)
https://www.lonza.com/about-us/our-locations/tuas-singapore
Ann: FDA Schedules GvHD Pre-License Manufacturing Inspection, page-166
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