Octapharma Pharmazeutika Produktionsgesellschaft M.B.H. FDA Inspection Record
Octapharma Pharmazeutika Produktionsgesellschaft M.B.H. is an FDA-registered facility (FEI 3002809097) located in A-1100, AT. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 5 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- Dec 16, 2022: Voluntary Action Indicated (VAI)
- Inspections on record
- 5 (5 VAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Form 483 and inspection documents
- 1 in FDA's reading room
- Recalls as the recalling firm
- 1, latest Aug 11, 2025
- Import refusals
- 1
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Dec 16, 2022 | Voluntary Action Indicated (VAI) | No citations listed |
| Apr 16, 2019 | Voluntary Action Indicated (VAI) | No citations listed |
| Jan 17, 2017 | Voluntary Action Indicated (VAI) | No citations listed |
| Mar 5, 2015 | Voluntary Action Indicated (VAI) | No citations listed |
| Dec 18, 2012 | Voluntary Action Indicated (VAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Aug 11, 2025 | Class II | B-0152-2026 | Immune Globulin (Human); Octagam IVIG 10% 30gm/300mL (Batch KP12B8561) Octapharma Pharmazeutika Produktionsgesellschaft m.b.H. is recalling distributed Octagam IVIG 10% 30gm/300mL (Batch KP12B8561) as they fell… |
Form 483s and inspection documents
FDA record score
11 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.
6 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Class II recall B-0152-2026, this FEI as the recalling firm | Aug 11, 2025 | 4 x 1 | 4 |
| Inspection classified VAI | Dec 16, 2022 | 6 x 0.6 | 3.6 |
| Inspection classified VAI | Apr 16, 2019 | 6 x 0.25 | 1.5 |
| Inspection classified VAI | Jan 17, 2017 | 6 x 0.25 | 1.5 |
| Inspection classified VAI | Mar 5, 2015 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Dec 18, 2012 | 10 years or older, so it adds no points | 0 |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 15, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
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Facility details
- Company
- Octapharma Pharmazeutika Produktionsgesellschaft M.B.H.
- Location
- A-1100 (AT)
- Registration Expires
- Dec 31, 2026
- Operations
- ANALYSIS; LABEL; MANUFACTURE; PACK
- Source
- decrs