FDA Warning Letter
The United States Food and Drug Administration (FDA) issued a warning letter to the following drug manufacturer, citing numerous violations. The warning letter is downloadable below in PDF.
November 5, 2015
Mr. Satish Reddy
Dr. Reddy’s Laboratories Ltd.
8-2-337, Road No 3, Banjara Hills, Hyderabad 500034
Andhra Pradesh 530 046, India
Dear Mr. Reddy:
The U.S. Food and Drug Administration (FDA) inspected the following three Dr. Reddy’s Laboratories Ltd. pharmaceutical manufacturing facilities in India:
- A. November 17-21, 2014: Dr. Reddy’s Laboratories Limited CTO Unit VI, located at APIIC Industrial Estate, Pydibhimavarma (Village), Ranasthalam Mandai, Srikakulam District, Andhra Pradesh;
- B. January 26-31, 2015: Dr. Reddy’s Laboratories Limited CTO Unit V, located at Peddadevulapally Village, Tripuraram, Mandal, Miryalguda Taluk, Nalgonda District, Telangana; and
- C. February 26 to March 6, 2015: Dr. Reddy’s Laboratories Ltd., Unit-VIIlocated at Plot No. P1 to P9, Phase III, Duvvada, VSEZ, Visakhapatnam, Andhra Pradesh.
At Dr. Reddy’s Laboratories Limited CTO Units VI and V facilities, we identified significant deviations from current good manufacturing practice (CGMP) for the manufacture of active pharmaceutical ingredients (APIs). At Dr. Reddy’s Laboratories Limited Unit-VII facility, we found significant violations of CGMP regulations for finished pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211.
These deviations and violations cause your APIs and finished drug products to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 351(a)(2)(B). The methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.
We reviewed your firm’s responses of December 15, 2014, February 19, 2015, and March 27, 2015. We note that they lack sufficient corrective actions. We received your additional correspondence of January 31, April 9, May 13, May 21, July 14, and September 14, 2015.
Our investigators observed specific deviations and violations during the inspection, including, but not limited to, the following.
A. Dr. Reddy’s Laboratories Limited CTO Unit VI Facility (FEI: 3002949085)
B. Dr. Reddy’s Laboratories Limited CTO Unit V (FEI: 3005447965)
C. Dr. Reddy’s Laboratories Limited Unit VII (FEI: 3006549835)
Violations and deviations cited in this letter are not intended as an all-inclusive list. You are responsible for determining the causes of these violations and deviations, for preventing their recurrence, and for preventing other violations and deviations.
These items, as well as other deficiencies our investigators found, lead us to question the effectiveness of your current corporate quality system to achieve overall compliance with CGMP.
Several violations are recurrent or represent long-standing failures to adequately resolve significant manufacturing quality problems. It is apparent that you have not implemented a robust quality system at your sites.
Dr. Reddy’s corporate management is responsible for ensuring the quality, safety, and integrity of all drugs you manufacture. FDA strongly recommends that you evaluate global manufacturing operations to ensure compliance with CGMP regulations and requirements, comprehensively and immediately.
If, as a result of receiving this warning letter or for other reasons, you are considering a decision that could reduce the number of active pharmaceutical ingredients and/or finished products produced by your manufacturing facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately, as you begin your internal discussions, at email@example.com. so that we can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances in your drug manufacture under 21 U.S.C. 356C(a)(1) and allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products. In appropriate cases, you may take corrective action without interrupting supply, or to shorten any interruption, thereby avoiding or limiting drug shortages.
Until you complete all corrections and FDA confirms your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug product or API manufacturer. If you fail to correct these violations, under Section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3), FDA may also refuse admission of articles into the United States manufactured at:
- A. Dr. Reddy’s Laboratories Limited, CTO Unit VI, APIIC Industrial Estate, Pydibhimavarma (Village), Ranasthalam Mandai, Srikakulam District, Andhra Pradesh, India
- B. Dr. Reddy’s Laboratories Limited, CTO Unit V, Peddadevulapalli, Tripuraram, Mandal, Miryalguda Taluk, Nalgonda District, Telangana, India
- C. Dr. Reddy’s Laboratories Limited Unit VII, Plot No. P1 to P9, Phase III, Duvvada, VSEZ, Visakhapatnam, Andhra Pradesh, India
Under Section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3), articles may be refused admission because manufacturing methods and controls do not appear to conform to CGMP within the meaning of Section 501 (a)(2)(B) of the FD&C Act, 21 U.S.C. 351 (a)(2)(B).
Within 15 working days of receipt of this letter, please notify this office, in writing, of the specific steps that you have taken to correct and prevent repeating these deviations and violations. In addition to the specific requests noted above, supporting documentation should include a third party assessment of the following:
1. A comprehensive evaluation of the extent of inaccuracies in recorded and reported data. Include a detailed action plan to fully investigate the extent and root causes of your deficient documentation and data management practices.
A risk assessment of the potential effects of observed failures on the quality of your drug products, including the effects of your deficient practices on the quality of drug products released for distribution and whether submissions to FDA may have been impacted. Conduct the same assessment for APIs that are components of drugs in applications that not yet been approved but which are pending before the FDA.
2. A management strategy for your firm that includes the details of your global corrective action and preventive action plan. Actions you have taken or will take may include:
- contacting your customers
- recalling product
- conducting additional testing
- adding lots to your stability programs to assure stability
- monitoring complaints
- revising procedures
- implementing new controls
- training or re-training personnel
If you cannot complete corrective actions within 15 working days, state the reasons for the delay and the date by which you will have completed the corrections. If you no longer manufacture or distribute the drug products or APIs at issue, provide the date(s) and reason(s) you ceased production. Send your reply to:
Please identify your response with FEI 3002949085 (CTO Unit VI), FEI 3005447965 (CTO Unit V), and FEI 3006549835 (Unit VII).
Director, Office of Manufacturing Quality, Office of Compliance, Center for Drug Evaluation and Research
- CPGM 7346.832 Pre-Approval Inspections
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Last Updated: 2015-11-26