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# 10 Observations on Genetech FDA-483
- URL: https://www.fdaweb.com/10-observations-on-genetech-fda-483/
- Published: 2019-03-13T12:00:00.000Z
- Updated: 2026-09-15T01:12:23.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5143593

FDA has just released the FDA-483 issued following a 6/18-6/22/18 inspection at Genetech, a San Diego, CA, umbilical cord processing facility. The 10 inspection observations are: 

- the eligibility of an HCT/P donor was not determined and documented by a responsible person, based on results of donor screening and donor testing;
- communicable disease agent tests were not FDA-licensed, approved, or cleared donor screening tests;
- procedures for all steps performed in the determining of donor eligibility of HCT/Ps were not established, implemented, followed, and reviewed;
- there is no quality control unit;
- aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
- the batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in processing;
- control procedures are not established that validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product;
- there is no written testing program designed to assess the stability characteristics of drug products;
- aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions; and
- distribution records do not contain the name and address of consignee and date and quantity shipped.