Shocked! Many warning letters of FDA are on the Internet, such as mylan, Xerox

Today, the FDA has sent out a series of warning letters, involving Indian pharmaceutical companies cadilla healthcare, swabplus and mylan These companies are suspected of cGMP violations to varying degrees, mainly due to the non-compliance of cleaning and sterility requirements Details are as follows: cadillahealthcare is one of the largest privately owned pharmaceutical companies in India In the past 60 years, the company has been developing and manufacturing pharmaceutical products in India, and the products have been sold to 85 countries around the world Cadila's main products include cardiovascular drugs, gastrointestinal drugs, analgesics, blood tonics, anti infection and antibiotic drugs, respiratory disease drugs, hypoglycemic drugs and immune drugs During the period from April 22 to May 3, 2019, the US Food and Drug Administration (FDA) found the following illegal operations at Cadila healthcare's plant in Ahmedabad: 1 Failure to clean, maintain and (depending on the nature of the drug) disinfect production equipment and appliances at appropriate intervals to prevent malfunctions or contamination, thereby changing the safety, characteristics, strength, quality or purity of the drug beyond official or other regulatory requirements FDA Staff observed residue after product replacement and equipment cleaning Serious equipment defects and cleaning defects lead to cross contamination between drugs 2 Failure to thoroughly investigate any unexplained deviation, batch or in batch component failure to meet specifications, whether or not the batch has been sold 3 Failure to follow appropriate written procedures designed to prevent microbiological contamination of claimed sterile drugs and to include verification of all sterility and sterilization processes The FDA accused the company of poor sterility, inadequate cleanroom design and smoke research During the inspection, it was found that the operator leaned over the opened aseptic plug bags, which were then led into the plug chute; the operator's hand crossed the aseptic plug chute and the aseptic plug that had been added into the chute, etc., which were all illegal operations 4 Not enough systems have been established to monitor the environmental conditions of aseptic processing area The letter mentioned that the company's production environment and personnel monitoring plan were defective Original text of warning letter: http://suo.im/5b86uc swabplus L.P the world's unique disposable swabplus patented product of spower swabplus group has ushered in a new era of portable care with its exquisite design and convenient use The product range includes beauty care, oral care, cleaning care, family health care, pet care, etc In May 2005, global Xerox Pharmaceutical (Weifang) Co., Ltd was established in China, and now it is controlled by revisionpharma group During the period from March 19, 2019 to April 11, 2019, the U.S Food and Drug Administration (FDA) inspected the plant in kukameng ranch City, and found the following problems: 1 Failure to identify the purity, strength and quality of the samples of each component and to meet all requirements, and failure to verify and determine the reliability of the test analysis provided by the supplier of the component within the appropriate time interval The company's over-the-counter (OTC) products are labeled with indications for ulcers and open wounds However, the properties, purity, strength and other appropriate quality properties of the incoming ingredients, including the active ingredient benzalkonium chloride, were not tested Instead, rely on the supplier analysis certificate (COA) of the non-conforming supplier FDA requires that each batch of ingredients used in drug production be identified and tested Only when the supplier's test results are verified at appropriate intervals, can COA be relied on to determine the properties of other ingredients 2 Failed to carry out necessary laboratory tests on each batch of drugs, required that they do not contain harmful microorganisms, and failed to determine the accuracy, sensitivity and specificity of their test methods The microbiological test method used by the company is not suitable, and there is a lack of appropriate validation for the analytical test method 3 Failure to establish a quality control department responsible for and authorizing the approval or rejection of all ingredients, drug containers, bottle caps, work in progress, packaging materials, labels and drugs, including drugs manufactured, processed, packaged or held under contract by another company; failure to establish adequate written responsibilities and procedures applicable to the quality control department 4 Failure to implement appropriate controls on computers or related systems to ensure that only authorized personnel can change production and control records or other records The company failed to properly control the high performance liquid chromatography (HPLC) and Fourier transform infrared spectrometer (FTIR) systems For example, there is no unique user name established for each analyst In addition, a backup copy of the original data of the laboratory equipment was not properly maintained Original warning letter: http://suo.im/5qaxfm mylanlaboratories limited, Unit8 mylanlaboratories Limited is a subsidiary of mylan company, a world-famous generic and pharmaceutical company, which is headquartered in Hyderabad, India and mainly operates nine pharmaceutical intermediates manufacturing plants in China and India The food and Drug Administration (FDA) inspected the company's plant in vizia nagram, Andhra Pradesh, India, from May 27 to June 5, 2019, and found the following two problems: 1 There are not enough written procedures for receiving, identifying, testing and processing raw materials The company's procedures for receiving, identifying, testing and handling raw materials are insufficient to ensure the suitability of materials used in production, including prevention of contamination and cross contamination with impurities Based on the evaluation of the API production process, the company did not anticipate the presence of impurities 2 Failure to clean equipment and utensils to prevent contamination or carryover will change API quality beyond official or other regulations The company can't guarantee that the cleaning method is enough to clean and prevent contamination or carry drugs produced on non special equipment, and FDA investigators observed that some production equipment was marked as clean However, some stains were observed when wiping the inner surface of the equipment chute with a lint free cloth Subsequent tests determined that the stain was the residual valsartan API Original text of warning letter: http://suo.im/4odirh the pharmaceutical industry in India has grown rapidly in the past 10 years Although the market size is smaller than some of the world's mainstream pharmaceutical markets (such as the United States, China, Japan), some leading pharmaceutical companies in India have more and more influence on the global pharmaceutical market At this stage, India is the world's largest producer of generic drugs Within one day, two pharmaceutical companies in India were warned by the FDA, which also raised some concerns about industry norms Editor in charge | Jenny tortoise statement: this point of view only represents the author, not the position of yaozhi.com, welcome to exchange and supplement in the message area; 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