Novartis Pharmaceuticals Corp. — FDA Facility Profile
Novartis Pharmaceuticals Corp. is an FDA-inspected facility (FEI 2416082) located in Suffern, NY, US. RegDataLab tracks 9 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Jul 14, 2015: No Action Indicated (NAI)
- Inspections on record
- 9 (6 VAI, 3 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
- 21, latest Jul 28, 2015
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jul 14, 2015 | No Action Indicated (NAI) | No citations listed |
| Feb 11, 2014 | No Action Indicated (NAI) | No citations listed |
| Dec 19, 2012 | Voluntary Action Indicated (VAI) | Absence of Written Procedures (21 CFR 211.100(a)) Review of representative number of batches (21 CFR 211.180(e)(1)) |
| Jan 31, 2012 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Establishment of time limitations (21 CFR 211.111) Theoretical yield statement including percentages (21 CFR 211.186(b)(7)) |
| Dec 21, 2010 | Voluntary Action Indicated (VAI) | SOPs not followed / documented (21 CFR 211.100(b)) Absence of Written Procedures (21 CFR 211.100(a)) Testing and release for distribution (21 CFR 211.165(a)) Written program not followed (21 CFR 211.166(a)) and 6 more |
| Sep 16, 2010 | Voluntary Action Indicated (VAI) | Procedures are written, and followed (21 CFR 211.130) Packaging line inspection before use (21 CFR 211.130(e)) |
| Feb 9, 2010 | Voluntary Action Indicated (VAI) | Absence of Written Procedures (21 CFR 211.100(a)) Labeling and packaging improperly approved/released (21 CFR 211.122(b)) Investigations of discrepancies, failures (21 CFR 211.192) Complaint Handling Procedure (21 CFR 211.198(a)) and 1 more |
| Mar 31, 2009 | Voluntary Action Indicated (VAI) | Backup file not maintained (21 CFR 211.68(b)) Calibration/Inspection/Checking not done (21 CFR 211.68(a)) Absence of Written Procedures (21 CFR 211.100(a)) Extent of discrepancy, failure investigations (21 CFR 211.192) |
| Nov 20, 2008 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Jul 28, 2015 | Class III | D-1430-2015 | Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules… Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour… |
| May 22, 2015 | Class III | D-1137-2015 | Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 12 Capsules… and 1 more product Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing. |
| Jul 30, 2014 | Class III | D-1516-2014 | Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, Manufactured… Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and… |
| May 28, 2014 | Class III | D-1387-2014 | Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60… Failed Stability Specification; out of specification result for particle size distribution during stability testing |
| Mar 3, 2014 | Class III | D-1227-2014 | Ritalin HCl (methylphenidate HCl) USP, 10 mg, 100 tablets per Bottle, Rx only, Mfd. by… and 1 more product Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was… |
| Aug 8, 2013 | Class II | D-326-2014 | Diovan (valsartan) 160 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample Not… and 14 more products Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol… |
| Jul 1, 2011 | Class II | D-724-2011 | Fanapt (iloperidone), 12 mg, 60-count bottle, Rx only, Distributed by: Vanda… Failed Tablet Hardness: During stability testing, a low out of specification (OOS) result for mean hardness was obtained; this decreased… |
| Jun 30, 2011 | Class III | D-762-2011 | Enablex (darifenacin) Extended-release tablets, 15 mg per tablet, 30 Tablet bottle, Rx… Failed USP Dissolution Test Requirements: Enablex 15 mg Tablets, Lot F0064 was found to be out of specification (OOS) for dissolution at 8… |
| Mar 25, 2011 | Class III | D-499-2011 | Valturna (aliskiren and valsartan) Tablets 300 mg/320 mg -- 300 mg aliskiren and 320 mg… Failed USP dissolution test requirements. |
| Mar 10, 2011 | Class III | D-444-2011 | Foradil Aerolizer (formoterol fumerate inhalation powder), 12 mcg per capsule, 60 Capsules… Out Of Specification Particle Size Distribution Test: During recent testing of Foradil Aerolizer Lot F0008 an out of specification (OOS)… |
Facility details
- Company
- Novartis Pharmaceuticals Corp.
- Location
- Suffern, NY (US)
- Source
- inspections