Ranbaxy Inc. FDA Inspection Record
Ranbaxy Inc. is an FDA-inspected facility (FEI 3003476632) located in Princeton, NJ, US. RegDataLab tracks 4 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- Jun 20, 2017: No Action Indicated (NAI)
- Inspections on record
- 4 (1 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
- 13, latest Jun 26, 2015
- Import refusals
- 5
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jun 20, 2017 | No Action Indicated (NAI) | No citations listed |
| Sep 4, 2014 | No Action Indicated (NAI) | No citations listed |
| Jun 22, 2011 | No Action Indicated (NAI) | Failure to develop written procedures (21 CFR 314.80(b)) Late submission of 15-day report (21 CFR 314.80(c)(1)(i)) Submission of report follow-up (21 CFR 314.80(c)(1)(ii)) Incomplete periodic safety report (21 CFR 314.80(c)(2)(ii)(A)) |
| Sep 29, 2009 | Voluntary Action Indicated (VAI) | Investigations of discrepancies, failures (21 CFR 211.192) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Jun 26, 2015 | Class II | D-1288-2015 | Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Cards/Box, Rx… Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell. |
| Jan 16, 2014 | Class II | D-1086-2014 | Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured… Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed… |
| Dec 27, 2012 | Class III | D-162-2013 | Lac-Hydrin (ammonium lactate) Lotion, 12%, packaged in 400 g bottles, Rx only, Ranbaxy… and 1 more product Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of… |
| Nov 9, 2012 | Class II | D-070-2013 | Atorvastatin Calcium Tablets, 10 mg, 90 tablets per bottle, Rx only, Manufactured for… and 2 more products Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates. |
| Aug 21, 2012 | Class II | D-060-2013 | Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured… Adulterated Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside… |
| Mar 16, 2012 | Class III | D-1405-2012 | Balnetar Therapeutic Tar Bath, Coal Tar USP 2.5% (from Coal Tar USP Solution, 7%), 7.5 oz… Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay. |
| Mar 11, 2011 | Class II | D-566-2011 | Calan SR (verapamil hydrochloride) SUSTAINED-RELEASE Caplets, 120 mg 100 count bottle, Rx… Marketed Without an Approved NDA/ANDA: The recall is being initiated because the Pfizer manufacturing site in Caguas, PR is currently not an… |
| Nov 2, 2010 | Class II | D-122-2011 | LORAZEPAM Tablets, USP, 0.5 mg, 90 tablets, Rx only, Manufactured for: Ranbaxy… Adulterated Presence of Foreign Tablets: A foreign tablet was discovered during the dispensing/counting of the medication |
| Sep 28, 2010 | Class III | D-094-2011 | Simvastatin Tablets USP 10 mg, 90 count (NDC 63304-790-90) and 1000 count (NDC… and 3 more products Incorrect Product Formulation; product contains the incorrect inactive ingredient Butylated Hydroxytoluene (BHT) instead of Butylated… |
| Mar 2, 2010 | Class II | D-383-2010 | Amoxicillin and Clavulanate Potassium for Oral Suspension, USP,
400 mg/5 mL; Rx only… Complaints received of 2 lots of Amoxicillin & Clavulanate Potassium for Oral Suspension turning brown upon reconstitution. The product… |
FDA record score
0 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.
9 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Class II recall D-1288-2015, this FEI as the recalling firm | Jun 26, 2015 | 10 years or older, so it adds no points | 0 |
| Class II recall D-1086-2014, this FEI as the recalling firm | Jan 16, 2014 | 10 years or older, so it adds no points | 0 |
| Class II recall D-070-2013, this FEI as the recalling firm | Nov 9, 2012 | 10 years or older, so it adds no points | 0 |
| Class II recall D-060-2013, this FEI as the recalling firm | Aug 21, 2012 | 10 years or older, so it adds no points | 0 |
| Class II recall D-566-2011, this FEI as the recalling firm | Mar 11, 2011 | 10 years or older, so it adds no points | 0 |
| Class II recall D-122-2011, this FEI as the recalling firm | Nov 2, 2010 | 10 years or older, so it adds no points | 0 |
| Class II recall D-383-2010, this FEI as the recalling firm | Mar 2, 2010 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Sep 29, 2009 | 10 years or older, so it adds no points | 0 |
| Class II recall D-1884-2009, this FEI as the recalling firm | May 1, 2009 | 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
- Ranbaxy Inc.
- Location
- Princeton, NJ (US)
- Source
- inspections