FDA Inspection
Cilag AGCilag AG – FDA Inspection, May 19, 2017
Record Details
This FDA Inspection record concerns Cilag AG, with an inspection on May 19, 2017, issued by the Office of Inspections and Investigations, covering human drugs.
View Company Profile
ID · ad1a9162-2fcb-4430-b953-e3c2def975c2
Inspection Facts
- Inspection number
- 1014940
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Cilag AG
10| Date | Classification | Office | Project area |
|---|---|---|---|
| June 24, 2025 | Not classified | Office of Inspections and Investigations | |
| September 23, 2024 | Not classified | Office of Inspections and Investigations | |
| May 5, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 16, 2019 | VAI | Center for Drug Evaluation and Research | New Drug Evaluation |
| December 8, 2017 | Not classified | Office of Inspections and Investigations |
Other documents for Cilag AG
- FDA Inspection 1279364 - 2025-06-24
- FDA Inspection 1257059 - 2024-09-23
- FDA Inspection 1208475 - 2023-05-05
- FDA Inspection 1096373 - 2019-07-16
- FDA Inspection 1046091 - 2017-12-08
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.