by Barbara Unger, FDAzilla GMP Quality Expert
INDIA | IMPORT ALERT 66-40 and Association with Warning Letters Regarding These Sites | Detention Without Physical Examination of Drugs from Firms Which Have Not Met Drug GMPs
In this post, I consider the active import alerts in the “66-40” category currently posted on the FDA website for firms located in India and the frequency with which warning letters are associated with the import alerts. The tabulated data does not identify import alerts that may have been put in place and removed within this time period. Addresses are often difficult to unambiguously align, but I’ve made every attempt to do so. Where warning letters have been issued, most link(s) are provided.
FROM THE FDA WEBSITE DESCRIBING IMPORT ALERT 66-40: “Foreign inspections of pharmaceutical manufacturers are being performed. Detention without physical examination may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practices (GMP’s).
Detention without physical examination (DWPE) may also be appropriate when the FDA receives information concerning inspections conducted by foreign or other government authorities under a Memorandum of Understanding or other agreement that reveals conditions or practices warranting detention of either particular products or of all products manufactured by a firm.
DWPE of such firms remains in effect until such time as the FDA is satisfied that the appearance of a violation has been removed, either by re-inspection or submission of appropriate documentation to the responsible FDA Center.
CONCLUSION:
- Currently 41 sites in India are under import alert for failure to comply with GMPs (Table 3).
- For these 41 sites, twenty-one of them, just under half do NOT have associated warning letters. Thus, being placed under import alert is no guarantee that a warning letter will be issued regarding the site nor is receiving a warning letter a guarantee of an import alert (Table 1).
- Among the active import alerts in this category, four have been issued to a single company, one firm has 3 sites under import alert, nine (9) firms have two sites under import alert and sixteen (16) have a single site under import alert. The firm with four sites is Sun Pharmaceuticals, and this includes sites that Sun acquired in their purchase of Ranbaxy Pharmaceuticals (Table 2).
- In three instances, EU reports of GMP non-compliance issued based on inspections in a similar timeframe. They are identified in Table 3 and summary reports may be found HERE.
TABLE 1: Import Alerts per Calendar Year
| Year | NUMBER of Alerts | Import Alerts With Associated Warning Letters | Import Alerts Without Associated Warning Letters |
| 2009 | 2 | 2 | 0 |
| 2010 | 0 | 0 | 0 |
| 2011 | 6 | 2 | 4 |
| 2012 | 0 | 0 | 0 |
| 2013 | 14 | 5 | 9 |
| 2014 | 8 | 7 | 1 |
| 2015 | 11 | 4 | 7 |
| 2016 | 0 | 0 | 0 |
| TOTAL to 3/26/2016 | 41 | 20 | 21 |
Figure 1. Import Alerts by Year and Those Without Associated Warning Letters
TABLE 2: Active Import Alerts (66-40) per Company Site in India, 2009 – 2016 to date
| COMPANY | NUMBER of SITES |
| Sun Pharmaceuticals (includes sites that were previously Ranbaxy sites) | 4 |
| Ipca Laboratories | 3 |
| Wockhardt, RPG Life Sciences, Nivedita Chemicals, Flemming Laboratories, Vignesh Life Sciences, Apotex, Pan Drugs, Micro Labs, Aarti Drugs Limited | 2 sites for each firm
(9 companies, 18 total alerts) |
| Stericon, Yag Mag Labs, Amsal Chem Pvt Ltd, Smruthi Organics, Sentiss Pharma, Unique Chemicals, Kamud Drugs, Konduskar, Aadivighnesh Chem, Canton Laboratories, Marck Biosciences, Emcure Pharmaceuticals, Sri Krishna Pharmaceuticals, Akorn India, Polydrug Laboratories, Magafine Pharma | 1 site for each firm(16 total) |
Table 3: Listing of firms/sites in India currently under Import alert 66-40, by Date of Issue
Links are provided to associated warning letters on the FDA website
| COMPANY | SITE | DATE | OTHER |
| Sun Pharmaceutical (previously Ranbaxy) | Village Ganguwala, Tehsil, Paonta Sahib, Simour District, Himachal Pradesh INDIA | 9/10/2009 | Archived |
| Sun Pharmaceutical (previously Ranbaxy) | Industrial Area No. 3, Madhya Pradesh, Dewas, Madhya Pradesh INDIA | 9/10/2009 | Archived |
| Stericon Pharma Pvt. Ltd. | No. 9, Sub Layout Of Plot 9, 1st Phase Bommasandra Ind. Area, Bangalore, Karnataka, INDIA | 1/13/2011 | Archived |
| Fleming Laboratories Ltd. | Survey 270, Navabpet Village, Medak, Andhra Pradesh INDIA | 4/8/2011 | No warning letter posted. This site was the subject of a EU GMP report of non-compliance by the French authorities based on an inspection of October 11, 2013. |
| Fleming Laboratories Limited | Plot No. 48, Temple Rock Enclave, Tarbund X Road, Secunderabad, INDIA | 4/11/2011 | No warning letter posted |
| Yag Mag Labs Private Limited | Survey No. 10, Gaddapotharam Village, Jinnatam Mandel, Medak District, AP, INDIA | 9/13/2011 | Archived |
| Nivedita Chemicals P lTd | A14 MIDC Andheri East, Mumbai, IN-MH INDIA | 11/23/2011 | No warning letter posted |
| Nivedita Chemicals Pvt. Ltd. | A-14 M.I.D.C. Andheri (East), Maharashtra, MS INDIA | 11/23/2011 | No warning letter posted |
| Amsal Chem Pvt. Ltd. | A-1/401-402-403, GIDC, Ankleshwar, Gujarat, INDIA | 4/11/2013 | No warning letter posted |
| Wockhardt Limited | Plot H-14/2, Biotech Park, M.I.D.C. Area Waluj, Aurangabad, Maharashtra INDIA | 5/22/2013 | Warning Letter, July 18, 2013 |
| Smruthi Organics Limited | Plot No. A-27, MIDC, Chincholi, Solapur District, Maharashtra, INDIA | 6/3/2013 | Warning Letter, March 6, 2014 This site was the subject of an EU GMP non-compliance report based on an inspection by authorities of the Netherlands, conducted on Oct 16, 2013. |
| RPG Life Sciences Limited | 25, M.I.D.C. Land, Thane-Belapur Road, Thane, Maharashtra INDIA | 6/10/2013 | Warning Letter, May 28, 2013 |
| RPG Life Sciences Limited | 3102/A G.I.D.C. Estate, 393002, Ankleshwar, Gujarat INDIA | 6/11/2013 | Warning Letter, May 28, 2013 |
| Sentiss Pharma Pvt. Ltd. | Village Khera Nihla, Tehsil Nalargarh, District Solan, Himachal Pradesh INDIA | 6/20/2013 | No warning letter posted |
| Unique Chemicals | Plot P-10, Shiv Mahape Gansoli, Thane Belapur Road, Maharashtra State, Rabale, Maharashtra INDIA | 6/28/2013 | No warning letter posted |
| Vignesh Life Science Pvt Ltd | 202 Sarada Residency, H – 26, Madhura Nagar Ameerpet, Hyderabad, Tamil Nadu INDIA | 6/28/2013 | No warning letter posted |
| Vignesh Life Sciences Pvt., Ltd. | 93 & 94 P Mundargi Industrial Estate, Bellary Karnataka, INDIA | 6/28/2013 | No warning letter posted |
| Kamud Drugs Pvt. Ltd. | N-608, MIDC, Kupwad, Sangli, M.S., INDIA | 7/10/2013 | No warning letter posted |
| Konduskar Laboratories Pvt Ltd | T-47 Kagel Hatkanangale Five Star, MIDC, Talandage (Village), Tal: Kagal, Maharashtra State, INDIA | 7/10/2013 | No warning letter posted |
| Micro Labs Limited | Plot No. 113-116 4th Phase KIADB, Bommasandra Industrial Area, Anekal Taluk, Bangalore, INDIA | 8/21/2013 | No warning Letter posted |
| Sun Pharmaceutical Industries (prev. Ranbaxy) | SEZ Unit 1, Plot No. A-41, Industrial Area Phase VIII-A, SAS Nagar, Mohali, Punjab INDIA. This site and data are listed twice on the FDA site but are listed here only once. | 9/13/2013 | No warning letter posted |
| Wockhardt Limited | L-1, MIDC Area, Jalgaon Road 43, Chikalthana, Aurangabad, Maharashtra INDIA | 11/26/213 | Warning Letter, November 25, 2013 |
| Marck Biosciences Ltd. | Plot No. 876, N.H. – 8, Vill: Hariyala, Tal: Matar, Kheda, Gujarat INDIA | 3/12/2014 | Archived |
| Sun Pharmaceutical Industries Limited – Karkhadi | Plot No. 817/A, Village – Karkhadi, Taluka – Padra District, Vadodara, Gujarat, INDIA | 3/12/2014 | Warning Letter, May 7, 2014 |
| Ipca Laboratories Ltd | 1 Pharma Zone, Pithampur, Madhya Pradesh INDIA | 3/25/2014 | Warning Letter, Jan 29, 2016 |
| Apotex Pharmachem India Pvt Ltd. | Plot No.: 1A, Bommasandra, Industrial Area, 4th Phase, Bangalore, INDIA | 4/1/2014 | Warning Letter, June 16, 2014 |
| Canton Laboratories Pvt. Ltd. | 110 A & B Gidc Estate, Makarpura Road; M I Estate, Vadodara, Gujarat INDIA | 4/10/2014 | Warning Letter, February 27, 2014 |
| Aadivighnesh Chem PVT. LTD. | A/7 Badrinath Apartment, Simpoli Road, Borivali (West), Mumbai, Maharashtra INDIA | 5/5/2014 | No warning letter posted |
| Micro Labs Limited | S – 155 Plot No, Verna Industrial Estate, Vasco Da Gama, Goa INDIA | 9/19/2014 | Warning Letter, January 9, 2015 |
| Apotex Research Private Limited | Plot 1/2, Site #2 Bommasandra Ind. Area, 4th Phase, Jigani Link Rd., Jigani Hobli, Bangalore, Karnataka State INDIA | 9/22/2014 | Warning Letter, January 30, 2015 |
| Ipca Laboratories Limited | Village Sejavta, Ratlam, Madhya Pradesh INDIA | 1/22/2015 | Warning Letter, Jan 29, 2016 |
| Aarti Drugs Limited | Plot No. E-22, M.I.D.C., Tarapur, Palghar, Maharashtra INDIA | 3/23/2015 | Only Warning Letter is a previous one dated July 30, 2013 |
| Aarti Drugs Limited | G-60 Boisar MIDC Tarapur, Tal. Palghar, District Thane, Tarapur, Maharashtra INDIA | 3/23/2015 | Only Warning Letter is a previous one dated July 30, 2013 |
| Ipca Laboratories Ltd | 1 Pharma Zone, Pithampur, Madhya Pradesh INDIA | 3/24/2015 | Warning Letter, Jan 29, 2016 |
| Ipca Laboratories Ltd | Plot No. 65 and 99, Danudyog, Ind. Estate, Piparia, Silvasa (D and NH), INDIA | 3/24/2015 | Warning Letter, Jan 29, 2016 |
| Pan Drugs Ltd. | 167-168, GIDC Nandesari Ind. Estate, Nandesari, Vadodara, Gujarat INDIA | 5/5/2015 | Warning Letter, September 2, 2015 |
| Emcure Pharmaceuticals Limited | Plot No. P-1 & P-2, IT-BT Park Phase II, MIDC, Hinjwadi, Hinjwadi, Pune, Maharashtra INDIA | 7/13/2015 | Warning Letter, March 3, 2016, |
| Sri Krishna Pharmaceuticals Ltd. – Unit II | A-35, IDA, Nacharam, Hyderabad, Andhra Pradesh, INDIA | 8/13/2015 | No warning letter posted. An EU Summary Report of Non-compliance was issued based on an inspection of December 4, 2014 conducted by Italian authorities. |
| Akorn India PVT | Khasra 5/1, 5/2, 5/3 Village, Nihalgarth Tehsil, Paonta Sahib, Simour, Himachal Pradesh INDIA | 8/21/2015 | No warning letter posted |
| Polydrug Laboratories Pvt. Ltd. | Plot N37, Ambernath Industrial Area, Anand Nagar MIDC, Mumbai, Maharashtra INDIA | 9/11/2015 | No warning letter posted |
| Megafine Pharma (P) Limited | 48 – 51/201 Plot No 31 – 35, Lakhamapur, Maharashtra INDIA | 10/14/2015 | No warning letter posted |
| Pan Drugs Limited | 192 G I D C Makarpura Industrial Estate, M I Estate, Vadodara, Gujarat INDIA | 12/08/2015 | No warning letter posted |