Aurobindo Pharma USA. We acknowledge that your firm engaged a consultant to assist your firm in meeting CGMP requirements. The .gov means it’s official.Federal government websites often end in .gov or .mil. contamination at levels above the acceptable limit. Based upon the nature of the deviations we identified at your firm, we strongly recommend engaging a consultant qualified to evaluate your operations. Under the same authority, articles may be subject to refusal of admission, in that the methods and controls used in their manufacture 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. Adderall ® 7.5 mg and 10 mg contain FD&C Blue #1 Aluminum Lake as a color additive. Your firm’s executive management remains responsible for fully resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance. They referred me to the PDF of the inspection results on 9/1/2017. FDA cited similar CGMP observations at other facilities in your company’s network. © 2020 Questex LLC. 279 Princeton Hightstown Rd. We acknowledge that you have initiated additional process controls and are now testing all manufactured batches of (b)(4) API for (b)(4), including (b)(4), as batch release criteria. Your investigation into this finding did not sufficiently extend to other drug manufacturing equipment that may also not be properly maintained. No. Manufacturing problems persist for Aurobindo, U.S.' second-largest generics producer, FDA finds Aurobindo sterile drug plant continues to have problems. Failure to correct these deviations may also result in FDA refusing admission of articles manufactured at Aurobindo Pharma Limited, Unit XI, Sy. Aurobindo was the mfr of my 1st-ever script for Adderall (and 1st-ever for any ADD med). You determined the stains were due to the formation of iron oxide (rust) inside the, . Dear Mr. N. Govindarajan: The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Aurobindo Pharma Limited (APL), Unit XI at Sy. Hyderabad 500038 You are responsible for investigating these deviations, for determining the causes, for preventing their recurrence, and for preventing other deviations in all your facilities. The agency this week posted a Form 483 for Aurobindo’s plant in Telangana with nearly a dozen observations but one overriding issue, the agency said. Silver Spring, MD 20993 Aurobindo Unit I and Aurobindo Unit IX were also inspected and cited for CGMP deficiencies related to the manufacture of, Recalls, Market Withdrawals and Safety Alerts, Inspections, Compliance, Enforcement, and Criminal Investigations, Aurobindo Pharma Limited - 577033 - 06/20/2019. The FDA finding comes as the Indian drugmaker has significantly increased its footprint the U.S. generics market with three plants, 750 employees and a portfolio of 300 drugs it acquired in September from Novartis’ Sandoz unit for $1 billion. Still clouded, foggy thinking, heart rate & breathing all same at normal levels, the only difference was I'm $40 in the hole. No. IMPORTANT UPDATE: The FDA is aware of the issue. You reported that recovered (b)(4) is generated from a (b)(4), which is recovered at your contract manufacturer, (b)(4). The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Aurobindo Pharma Limited (APL), Unit XI at Sy. Any DMF update should also result in notifications to any authorized person for the DMF. Conduct a thorough review of all batches of API made at Aurobindo that shows unknown impurities above the reporting thresholds. Specify what you have done since our inspection to correct your deviations and to prevent their recurrence. Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. However, your response is inadequate because you did not identify corrective actions to ensure other equipment used to manufacture drugs have contact surfaces that are also made of adequate material. impurities in all API manufactured at your firm. For FDA’s current thinking on control of potentially mutagenic impurities, see FDA’s guidance document M7(R1) Assessment and Control of  DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk for approaches that FDA considers appropriate for evaluating mutagenic impurities, at https://www.fda.gov/media/85885/download. I have taken Adderall at varying dosages daily for the past 10 years for ADHD and recently picked up a prescription from CVS by the brand name "Aurobindo Pharma". Subscribe to FiercePharma to get industry news and updates delivered to your inbox. Failure to ensure that equipment surfaces in contact with API do not alter the quality of the API beyond the official or other established specifications. I usually get Teva or Barr generic, sad to say I made the same mistake you did. The FDA finding comes as the Indian drugmaker has significantly increased its … Aurobindo Pharma USA. All rights reserved. Changes to methods or controls were not reported to FDA through a supplement to an approved (b)(4). India, 10903 New Hampshire Avenue FDA considers the expectations outlined in ICH Q7 when determining whether API are manufactured in conformance with CGMP. If you have issues with Aurobindo brand Adderall, report it to the FDA. These impurity levels are also above the ICH Q3A(R2) reporting threshold for drug substance impurities. Aurobindo Pharma Ltd. brand List that includes tablets, capsules, syrups, etc. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. After you receive this letter, respond to this office in writing within 15 working days. This Aurobindo is NOT a good generic for Adderall. Until you correct all deviations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer. Of course, it is yet to be seen how Aurobindo will fare with the drugs, given that Sandoz tossed them off for having insufficient margins in a very challenged U.S. generics market. 2, Maitrivihar, Ameerpet Aurobindo, which is growing its reach in the U.S., has had another sterile drug manufacturing plant criticized by the FDA. Provide a CAPA plan that includes a full review of all equipment contact surfaces to determine if they are reactive/additive to your drugs and whether contact surfaces are suitable for intended use. They don't taste anything like normal Adderall IR (Sugary), and i literally feel as if i haven't taken any medication. Our investigators observed what appeared to be rust on more than, In your response, you acknowledged that your firm did not check the dryness of the inner surface of the, after cleaning: therefore, moisture remained in the, and caused discoloration. Provide copies of these notifications to FDA. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Aurobindo Unit I and Aurobindo Unit IX were also inspected and cited for CGMP deficiencies related to the manufacture of (b)(4) API and intermediates. United States, Via UPS                                                                                 Warning Letter 320-19-27. Identify any impurities that are present at a level greater than the ICH Q3A(R2) identification thresholds and update your DMFs and. US FDA resumed approving products from Aurobindo Pharma’s unit-3 only around June following its inspection in March. Adderall XR with NDC 54092-383 is a a human prescription drug product labeled by Takeda Pharmaceuticals America, Inc.. Manufacturer Teva has issued a voluntary recall of two lots of generic Adderall, also known as amphetamine salts or amphetamine salt combo.. Failure to extend investigations to other batches that may have been associated with a specific failure or deviation. RELATED: FDA finds Aurobindo sterile drug plant continues to have problems. Aurobindo Pharma Limited is a pharmaceutical manufacturing company headquartered in HITEC City, Hyderabad, India. The site is secure. You determined the stains were due to the formation of iron oxide (rust) inside the (b)(4). 61-66, IDA, Pydibhimavaram, Ranasthalam (Mandal), Srikakulam District, AP, from February 4 to 9, 2019. 351(a)(2)(B). Your investigation into the root cause of (b)(4) impurities, such as (b)(4), in your (b)(4) and (b)(4) API was deficient. After you were informed by the European Directorate for the Quality of Medicines (EDQM) that their test results showed your (b)(4) API contained (b)(4), your firm tested more than (b)(4) API batches and determined that (b)(4) batches, approximately (b)(4)%, contained (b)(4) contamination at levels above the acceptable limit. From February 4 to 9, 2019 for drug substance impurities correct your deviations and to their. Apotex Corp Issues Voluntary Recall of Drospirenone and Ethinyl Estradiol tablets ; 4... It ’ s obligation to comply with Submission requirements for Supplements and other changes to an Approved ( b (. 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