Leo Pharma Inc — FDA Facility Profile
Leo Pharma Inc is an FDA-inspected facility (FEI 3008023673) located in Parsippany, NJ, US. RegDataLab tracks 2 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Sep 19, 2014: Voluntary Action Indicated (VAI)
- Inspections on record
- 2 (1 VAI, 1 NAI)
- 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
- Recalls as the recalling firm
- 1, latest Feb 10, 2011
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Sep 19, 2014 | Voluntary Action Indicated (VAI) | Failure to develop written procedures (21 CFR 314.80(b)) Late submission of 15-day report (21 CFR 314.80(c)(1)(i)) |
| May 20, 2013 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Feb 10, 2011 | Class II | D-409-2011 | Innohep (tinzaparin sodium injection) multidose vial; 20,000 IU/mL, Rx only, Manufactured… Presence of particulate matter; glass, metal |
Facility details
- Company
- Leo Pharma Inc
- Location
- Parsippany, NJ (US)
- Source
- inspections