Drug factory · FDA FEI 3002807200
F. Hoffmann-La Roche AG
Grenzacherstrasse 124, Basel, Switzerland
Problems found, fixed voluntarily at FDA's last inspection, May 9, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
9 drug inspections on record since 2009: 4 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 9, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 25, 2024 | No problems found | Bioresearch Monitoring | — |
| Jul 27, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 24, 2018 | No problems found | Drug Quality Assurance | — |
| Sep 23, 2016 | No problems found | Drug Quality Assurance | — |
| Mar 28, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 16, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 28, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | 11 |
| Jun 25, 2009 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Aug 28, 2009 inspection
- SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance. - Written in-process control procedures 21 CFR 211.110(a)
Written procedures are not established that describe the examinations to be conducted on appropriate samples of in-process materials of each batch. - Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established. - Validation lacking for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process. - Sterility/pyrogens - test methods written, followed 21 CFR 211.167(a)
Test procedures relative to appropriate laboratory testing for pyrogens are not followed. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing. - Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. - Written sanitation procedures not followed 21 CFR 211.56(b)
Written procedures for sanitation are not followed. - Written procedures lacking for use of pesticides etc. 21 CFR 211.56(c)
Written procedures are lacking for the use of cleaning and sanitizing agents designed to prevent the contamination of equipment, components, drug product containers, closures, and drug products. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine checking of automatic and electronic equipment is not performed according to a written program designed to assure proper performance. - Procedures To Be in Writing 21 CFR 211.80(a)
Written procedures are lacking which describe in sufficient detail the sampling and testing of components.
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.