As of March 4, the agency issued 45 Warning Letters this year. Cipla announced that the United States Food and Drug Administration (USFDA) conducted a cGMP inspection at its Goa manufacturing facility from 16-27 September 2019. For more USFDA warning Letter …Cross Brands Contract Filling, LLC           MARCS-CMS 589295 — December 17, 2019 For Warning Letter Click Here –   Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed …Teligent Pharma, Inc. MARCS-CMS 587592 — November 26, 2019 For Warning Letter Click Here –   Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. For more USFDA warning …Alkermes, Inc. MARCS-CMS 597260 — December 02, 2019 For Warning Letter Click Here –   Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. Some are related to food companies, while quite a few are related to “vaping” products. For more USFDA warning Letter …

Pharmaceutical Guidanace April 14, 2020 2019, FINISHED PRODUCT, USFDA WARNING LETTER Comments Off on USFDA Warning Letter for OHM Pharma, Inc 217 Views OHM Pharma, Inc. MARCS-CMS 586428 — November 19, 2019 The Indian pharmaceutical companies have received 19 warning letters, out of the 41 (46 per cent) issued by the Office of Manufacturing Quality of the US Food and Drug Administration (USFDA) in 2019, the most in four years. OHM Pharma, Inc. MARCS-CMS 586428 — November 19, 2019 For Warning Letter Click Here –   Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. Further, the FDA recommends the firm hire qualified consultant(s) to assist in bringing them into GMP compliance. The inspection ended with 12 observations, none of which are related to data integrity. According to a study by the Indian Pharmaceutical Alliance (IPA) and consultancy firm McKinsey, a couple of years ago, the number of FDA inspections in India declined from 272 in 2017 to 192 in 2015, but the share of plants receiving a clearance without adverse observations increased from 32 per cent to 51 per cent.If the Indian drug manufacturers accounted for nearly 50 per cent of the current good manufacturing practices (cGMP)-related warning letters in 2015, it reduced to less than 30 per cent in 2016. This reversed the recent trend wherein Indian companies had been increasingly complying with the standards and resolving their manufacturing quality issues quickly that had cropped up over the last four-five years.Most importantly, leading domestic firms such as Lupin, Aurobindo, Glenmark, Strides Arcolab, Zydus Cadila and more were slapped with warning letters in 2019. These included Mylan Laboratories' Unit 8 at Vizianagaram, Andhra Pradesh; Cadila Healthcare's unit at Moraiya, Ahmedabad; Torrent Pharmaceuticals's facility at Indrad, Gujarat; Glenmark Pharmaceuticals' unit at Solan, Himachal Pradesh; Lupin Limited's Unit 1 at Mandideep, Madhya Pradesh; Lantech Pharmaceuticals' active ingredient unit in Hyderabad; Emcure Pharma's Pune unit; CTX Lifesciences' unit at Surat, Gujarat; Indoco Remedies' unit at Vasco Da Gama, Goa; Strides Pharma Science's Puducherry unit; Aurobindo Pharma's Unit XI at Srikakulam, Andhra Pradesh; Rxhomeo's unit in Hyderabad; Glint Cosmetics's unit at Navi Mumbai; Centurion Laboratories's unit at Manjusar, Gujarat; B. Jain Pharmaceuticals's unit at Bhiwadi, Rajasthan; Jubilant Generics' unit at Uttaranchal; Hospira Healthcare's unit at Irungattukottai, Chennai; Anicare Pharmaceutical's unit in Navi Mumbai and Vipor Chemicals's Vadodara unit.The USFDA's Office of Manufacturing Quality (OMQ) at the Centre for Drug Evaluation Research (CDER) evaluates compliance with cGMP for drugs based on inspection reports and evidence gathered by USFDA investigators.