Dr reddys mexican api production plant has received an fda warning letter that details failures to validate analytical methods and other problems. Reddys, which this month also reported the fda had issued a form 483 for its formulations plant in bachupally that included 11 observations, four of them repeats. Us food and drug administration fda inspectors visited the plant in jiutepec, mexico towards the end of 2010 and alerted dr reddy s to shortcomings at the operation. Food and drug administration establishment inspection report. Us food and drug administration fda inspectors visited the plant in jiutepec, mexico towards the end of 2010 and alerted dr reddys to shortcomings at the operation. The agency this week posted a form 483 pdf for a dr. Dr reddy s mexican api production plant has received an fda warning letter that details failures to validate analytical methods and other problems.
Dr reddy s laboratories ltd on wednesday said it has received an establishment inspection report eir from us food and drug administration fda for its formulations plant located in a special economic zone at srikakulam in andhra pradesh. The third plant mentioned in the fdaissued warning letter, was the dr. Reddys gets observations from usfda for visakhapatnam. The plants under warning letter currently contribute about 10. Some are related to food companies, while quite a few are related to vaping products. Considering the procedural nature of observations, we.
That plant also was included in the 2015 warning letter. The fda noted the potential for sample contamination based on the way workers were handling vials. Reddys laboratories limited unitvii facility, we found significant violations of cgmp regulations for finished pharmaceuticals, title 21, code of federal regulations, parts 210 and 211. Gmp drug warning letters issued in calendar year 2015 data. Dr reddys usfda inspection of oncology formulation. This is not the first time dr reddys has fallen foul with the us. Dr reddys get us fda warning letter for quality issues in. Dr reddy s will not receive us approvals for drugs made at the plants until it the problems have been resolved. The warning letters followed the inspection of these sites by the usfda in november 2014, january 2015, and.
Adds four new warning statements to the drug facts labeling dfl and the selfhelp users guide consumer information leaflet regarding stomach ulcer, diabetes, seizure, and allergic reaction. Early preparation of a warning letter is likely to be based on 483s format which is a guide in the early preparedness to prevent severe lapses. Reddys bachupally plant has a version of fda deja vu. The fdas letter went on to describe many other alleged violations and concluded by noting that dr. Warning letter citation noting many deficiencies with laboratory systems and records. Food and drug administration fda issues warning letters to biopharma, medical device and food companies when they find that a manufacturer has significantly violated fda regulations. Nov 06, 2015 dr reddys laboratories today issued a statement acknowledging that it has received a warning letter issued by the usfda dated november 5, 2015 relating to api manufacturing facilities at. Department of health and human services silver spring md 20993.
Dr reddys laboratories says it is addressing the observations at its duvvada plant which was hit with a warning letter in 2015. Gmp drug warning letters issued in calendar year 2015 data integrity deficiencies january, 2016 the tabulation on pages 454 include full text of data integrity deficiencies identified in fda drug gmp warning letters issued in calendar year 2015. Warning letter pdf promotional material pdf nda 021876 diclegis doxylamine. Shares plunged as much as 23%a 17year lowbefore they recovered down just 4%, according to india media. Dr reddys laboratories in warning letter hits earning.
This page only covers office of prescription drug promotion formerly division of drug. Regulatory woes mount for dr reddys business standard. Dr reddys laboratories today issued a statement acknowledging that it has received a warning letter issued by the usfda dated november 5, 2015 relating to api manufacturing facilities at. Indias secondlargest drugmaker did have one important turn of. The us regulator has slammed indias emcure pharmaceuticals in a warning letter, accusing the company of slipshod investigation of tests showing microbial contamination and poor supervision, and has also sent a form 483 containing eight observations to dr reddys. Dr reddys get us fda warning letter for quality issues in 3. The fda this week posted a form 483 pdf for the dr. Dr reddys gets 8 usfda observations for duvvada injectable site. Reddys laboratoriess fda inspection, warning letter, form 483 observation details related to. Nov 05, 2015 surajit pal from prabhudas liladhar speaks on the news that dr. May 01, 2017 in february, the fda returned to a dr. Reddys laboratories has received a warning letter from the us fda relating to its api manufacturing facilities at srikakulam, andhra pradesh and miryalaguda, telangana, as well as an oncology formulation manufacturing facility.
Reddys laboratories has received a warning letter from the us fda relating to its api manufacturing facilities at srikakulam, andhra pradesh and miryalaguda, telangana, as well as an oncology formulation manufacturing facility at duvvada, visakhapatnam, andhra pradesh. Matters described in fda warning letters may have been subject to subsequent interaction between fda and the letter recipient that may. Dr reddys received the fda warning letter for cto unit vi, an api plant located in srikakulam district of andhra pradesh, cto unit v, also an. We know that the warning letter does not imply discontinuation of drugs supply to the us market. Dr reddys laboratories ltd has submitted to bse a copy of press release dated november 06, 2015 titled dr.
Reddys receives warning letter from us fda relating. Jul 26, 2019 as firms including laurus labs, natco and strides get gmp compliance nods, the fda has pulled up dr reddys for gmp compliance issues. Dr reddys api plant receives usfda 483 with nine observations. Reddys laboratoriess fda inspection, warning letter, form 483 observation details related to gmp quality systems on. Reddys lab receives warning letter from us fda nov 7. Reddys formulation plant in india appears stuck on regulatory repeat. As per the reports, dr reddys laboratories has received a warning letter in connection with the year 2015 in connection to current good manufacturing practice cgmp deviations in ap and telangana besides oncology formulation facility at duvvada. Reddys laboratories limited unitvii facility, we found significant violations of cgmp regulations for finished pharmaceuticals, title 21. Reddys oncology formulation duvvuda unit makes cytotoxic and hormonal injectables manufacturing facility at duvvada at visakhapatnam, andhra pradesh. Reddys had said that all the commitments as part of warning letter response have been completed and the three plants will be reinspected by the us regulator by end of march. Reddys problem with fda stems from a warning the agency issued to reddys in november 2015 that three of its facilities did not meet u. Dr reddys will not receive us approvals for drugs made at the plants until it the problems have been resolved. Us fda issues eir to dr reddys formulations facility in ap. This ealert is part of a monthly series of ealerts summarizing publiclyavailable fda enforcement letters i.
Warning letter citing inadequate data retention, security, and audit trails for laboratory systems. The warning letter said, this unknown individual performed injections and deletions without the analysts knowledge. The news came just days after reports about a form 483 issued to dr. As of march 4, the agency issued 45 warning letters this year. In august the us governments consumer product safety commission accused the firm of having violated childproof packaging rules, while an inspection of an api plant in mexico in 2010 was followed up with an fda warning letter banning imports from the site. Reuters reports that dr reddys laboratories ltd, indias secondlargest drugmaker, has received a warning letter from fda over inadequate quality controls at three manufacturing plants producing drugs for cancer and other diseases.
Seems like there is a slight tension in the company now. You can obtain 483s, eirs, inspectorprofiles, and more at the fdazilla store. In a filing saturday with the bombay stock exchange, indias secondlargest drugmaker said pdf that the agency had notified it that the steps. This warning letter is to inform you of objectionable conditions observed during the food and drug administration fda inspection of your clinical site from november 9, 2015, to december 8, 2015. There were only four observations, but they covered missteps in some of the basic tenets of quality manufacturing. Usfdas warning letter continues to haunt dr reddys even after 3. World leaders in health industry analysis the world generic market report 2012 volume i. Nov 10, 2015 reuters reports that dr reddy s laboratories ltd, indias secondlargest drugmaker, has received a warning letter from fda over inadequate quality controls at three manufacturing plants producing drugs for cancer and other diseases. Reddys laboratories is one the renowned pharmaceutical company in the telugu states. In a bombay stock exchange filing, dr reddys laboratories announced an audit at its duvvada, visakhapatnam facility in the indian state of andhra pradesh was completed today and resulted in a form 483. Drug maker dr reddys on october 8 said it got form 483 with 8 observations from us fda for its injectable plant in duvvada.
Reddy s laboratories limited unitvii facility, we found significant violations of cgmp regulations for finished pharmaceuticals, title 21, code of federal regulations, parts 210 and 211. Dr reddys lab gets usfda warning letter for 3 drug plants. Following the us fda action, shares of dr reddys laboratories witnessed a sharp dip to close the session on friday at rs 3629. Reddy s has been chastised for similar problems since at least 2008. Reddys had said that all the commitments as part of warning letter response have been completed and the three plants will be reinspected by the us regulator by end of. Us fda issues eir to dr reddy s formulations facility in.
The cost of an fda enforcement action is more expensive than the cost of a robust compliance process. The warning letter was issued by the fda to dr reddys on thursday for its srikakulam, miryalaguda and duvvada drug manufacturing plants all based in southern india. Food and drug administration fda warning letter to the company dated november 5, 2015 has been made available to the public on the fda s web site at. The worry on the three facilities in question at nalgonda in telangana and at srikakulam and visakhapatnam in andhra pradesh getting fda import. Reddys oncology drug plant escapes cloud of fda warning. Indias dr reddys says fda raises fresh concerns at. Reddys struggles to meet fda concerns august 7, 2017.
The drugmaker reported that the fda had completed an inspection of the facility in bachupally and cited it with 11 violations. Reddys laboratories plunge after fda warning letter on quality control by ab wire november 6, 2015 3. Reddys, which this month also reported the fda had issued a form 483 for its. Nov 06, 2015 following the us fda action, shares of dr reddys laboratories witnessed a sharp dip to close the session on friday at rs 3629. Nov 27, 2014 this is not the first time dr reddys has fallen foul with the us.
Fda warning for dr reddys pharmaceutical executive. The fda had earlier set a deadline for the company to respond within 15 days from the date of receiving the letter. Reddys racks up more repeat violations at bachupally formulations plant. Rdy today issued a statement acknowledging that it has received a warning letter issued by the us fda dated november 05, 2015 relating to its api manufacturing facilities at srikakulam, andhra pradesh. When the fda inspected the plant in 2017 it was cited withyouve got it11 violations. Reddys oncology drug plant escapes cloud of fda warning letter. Surajit pal from prabhudas liladhar speaks on the news that dr. Data sources include ibm watson micromedex updated 4 may 2020, cerner multum updated 4 may. Rdy further to our press release dated november 6, 2015, this is to inform you that the u. Dr reddys gets fda warning letter for three drug plants. Food and drug administration fda warning letter to the company dated november 5, 2015 has been made available to the public on the fdas web site at.
March 26, 2020 dr reddys laboratories, inc has notified its distributors to arrange for return of any recalled product. Fda sends warning letter to dr reddys api mexican plant. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Usfda had issued warning letter in november 2015 relating to current good manufacturing practice deviations at dr reddys api. Learn about the types of warning letters on fda s website. Reddys laboratories limited warning letter cgmpactive pharmaceutical ingredients apis 1152015. Reddys laboratories issues voluntary nationwide recall of phytonadione injectable emulsion usp, 10 mgml singledose ampules due to ampules breaking and shattering upon opening. Reddys receives warning letter from us fda relating to. Drug administration fda warning letter to the company dated november 5, 2015. Investor concern on dr reddys laboratories has deepened with details from the warning letter issued to the company by the us food and drug administration fda coming into the public domain. On the same note, you can catch the other form 483 issued to the api manufacturing.
Nov 06, 2015 the warning letter was issued by the fda to dr reddys on thursday for its srikakulam, miryalaguda and duvvada drug manufacturing plants all based in southern india. Reddys statement on the receipt of warning letter from. This is to inform you that the audit of our formulations. These letters are supplied by the cder freedom of electronic information office. Reddy s on 05 november 2015 identified similar data integrity concerns at another site. Links to the warning letter on the fda website are included as well as information regarding. Meanwhile, numaferm has struck a licensing deal and olon has started constructing a new plant.
The fda, which issued a warning letter to dr reddys laboratories on november 5. Reddys has been chastised for similar problems since at least 2008. The fda keeps rolling through the indian manufacturing plants of dr. Dr reddys, which derives a majority of its sales from the united states, said in statement that it had received an inspection letter known as. As firms including laurus labs, natco and strides get gmp compliance nods, the fda has pulled up dr reddys for gmp compliance issues.
758 1513 299 1492 1113 638 511 22 337 1123 498 1059 1479 1301 1379 1140 1018 1184 1145 527 616 3 352 272 784 950 1242 886 950 1120 123