FDA Inspection
Biological E. LimitedBiological E. Limited – FDA Inspection, Nov 12, 2024
Record Details
This FDA Inspection record concerns Biological E. Limited, with an inspection on November 12, 2024, issued by the Office of Inspections and Investigations, covering human drugs.
View Company Profile
ID · c9b21fc4-b052-490d-9d0e-35239cf7525e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1254353
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Biological E. Limited
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 26, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 15, 2023 | Not classified | Office of Inspections and Investigations | |
| February 8, 2023 | Not classified | Office of Inspections and Investigations | |
| August 2, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 26, 2018 | Not classified | Office of Inspections and Investigations |
Other documents for Biological E. Limited
- FDA Inspection 1239879 - 2024-04-26
- FDA Inspection 1209362 - 2023-06-15
- FDA Inspection 1197141 - 2023-02-08
- FDA Inspection 1136231 - 2019-08-02
- FDA Inspection 1071667 - 2018-10-26
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.