Company
GermanyBurgwedel Biotech GmbH, Burgwedel, Germany – FDA Inspections
Inspection records and compliance data for Burgwedel Biotech GmbH in Burgwedel, Lower Saxony. 3 FDA inspections on record, 3 Form 483s, last inspected August 07, 2026.
Company Profile
This profile covers Burgwedel Biotech GmbH based in Burgwedel, Lower Saxony, Germany.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 2
- Form 483s
- 3
- Warning letters
- 0
First inspected February 26, 2019. Last inspected August 7, 2026.
Most cited issue areas
- Deviations from laboratory control requirements1 inspection
- Procedures for sterile drug products1 inspection
- Sanitation--buildings not clean, free of infestation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 7, 2026 | Not classified | Biologics · Vaccines and Allergenic Products | 1332374 |
| August 29, 2023 | VAI | Biologics · Vaccines and Allergenic Products | 1216178 |
| February 26, 2019 | Not classified | Biologics | 1112854 |
FDA documents
Form 483s (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Burgwedel Biotech GmbH
FEI Number
3013514411
Address
Im Langen Felde 5, Burgwedel, Lower Saxony 30938, Germany
Country
Germany
ID: 0e5bd74d-d86f-477b-a3d7-cb7865573df9