Wyeth Lederle SRL FDA Inspection Record
Wyeth Lederle SRL is an FDA-registered facility (FEI 3002806766) located in Catania, IT. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 6 FDA inspections and 1 compliance action at this facility.
What FDA found at this site
- Latest inspection
- Nov 15, 2024: Voluntary Action Indicated (VAI)
- Inspections on record
- 6 (2 OAI, 3 VAI, 1 NAI)
- Last OAI inspection
- Nov 14, 2014
- Warning letters
- 1 listed by FDA for this FEI, latest Mar 27, 2013
- Import refusals
- 3
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Nov 15, 2024 | Voluntary Action Indicated (VAI) | No citations listed |
| Jan 21, 2022 | Voluntary Action Indicated (VAI) | No citations listed |
| Apr 20, 2017 | Voluntary Action Indicated (VAI) | Environmental Monitoring System (21 CFR 211.42(c)(10)(iv)) Procedures for sterile drug products (21 CFR 211.113(b)) Microbiological testing (21 CFR 211.165(b)) Complete test data included in records (21 CFR 211.194(a)) |
| Nov 14, 2014 | Official Action Indicated (OAI) | GMP Training Frequency (21 CFR 211.25(a)) Defined areas of adequate size for operations (21 CFR 211.42(c)) Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a)) Computer control of master formula records (21 CFR 211.68(b)) and 9 more |
| Jul 20, 2012 | Official Action Indicated (OAI) | No citations listed |
| Dec 4, 2009 | No Action Indicated (NAI) | No citations listed |
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 |
|---|---|---|---|
| Inspection classified VAI | Nov 15, 2024 | 6 x 1 | 6 |
| Inspection classified VAI | Jan 21, 2022 | 6 x 0.6 | 3.6 |
| Inspection classified VAI | Apr 20, 2017 | 6 x 0.25 | 1.5 |
| Inspection classified OAI | Nov 14, 2014 | 10 years or older, so it adds no points | 0 |
| Warning letter on FDA's dashboard, which does not show close-outs | Mar 27, 2013 | 10 years or older, so it adds no points | 0 |
| Inspection classified OAI | Jul 20, 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
- Wyeth Lederle S.R.L
- Location
- Catania (IT)
- Registration Expires
- Dec 31, 2026
- Operations
- ANALYSIS; LABEL; MANUFACTURE; PACK
- Source
- decrs