Another Chinese company was warned by the FDA's website!

According to the reporter from pharmaceutical intelligence media, Huai'an Zongheng Biotechnology Co., Ltd received a warning letter from the FDA on January 9, which pointed out that Huai'an Zongheng failed to test the product before leaving the factory; failed to test to confirm each component of the product; failed to establish and follow the stability test to determine the validity period Today, the full warning letter was posted on the FDA website The warning letter posted on the FDA website is as follows: warning letter 320-20-16 January 9, 2020 Dear Mr Li: the U.S Food and Drug Administration (FDA) inspected your drug manufacturing facility, human Zongheng bio Tech Co., Ltd., Fei 3007628845, at No 615 North Xiangyu Road, human, from July 1 to 5, 2019 This warning letter summaries Significant violations of current good manufacturing practice (CGMP) Regulations for finished pharmaceuticals See 21 CFR, parts 210 and 211 This warning letter summarizes major violations of CGMP regulations for finished drugs See 21 CFR, chapters 210 and 211   Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products 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 351 (a) (2) (b) Because your methods, facilities, manufacturing processes, packaging, or storage methods do not comply with CGMP regulations, your drug product is considered a violation under section 501 (a) (2) (b) of the federal food, drug, and Cosmetic Act (FD & C), 21 U.S.C 351 (a) (2) (b) We reviewed your July 25, 2019, response to our form FDA 483 in detail and acknowledge receipt of your subsequence response During our inspection, our inspector observed specific violations including, but not limited to, the following   1 Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, Prior to release (21 CFR 211.165 (a))   Your firm contract manufactures over-the-counter (OTC) (b)(4) drug products, including versions specifically marketed for children You released your drug products without adequate testing, including identity and strength testing for each active ingredient For example, you did not test drug products (b)(4) for their labeled active ingredient, (b) (4) prior to release Huai'an vertically and horizontally produces some over-the-counter drugs, including versions specially made for children Drug products were sold without adequate characterization and strength testing of each active ingredient Complete testing of each batch before release is essential to determine if the drug products you manufacture measure appropriate specifications   In your response, you provided third-party testing results for assay of (b)(4) contained in (b)(4) drug product lot of (b)(4) and (b)(4) drug product lot of (b)(4) You also provided the revised finished product specifications for both drug products to add the requirements for (b)(4) assay testing prior to release in the future In the reply of Huaian Zongheng, the third-party test results of some drug batches are provided, and the finished product specifications of the two revised drugs are also provided, so as to increase the test requirements of corresponding drugs before future release   Your response is inadequate Your testing was limited to assay, and you failed to specify and perform at least one test to verify the identity of (b)(4) in (b)(4) batch of drug product you manufacture containing the active ingredient Further, you failed to test all of your retain samples of drug products containing (b)(4) within expiry to determine whether they meet established specifications for identity and assay Your response is also inadequate because you did not include sufficient information about your testing procedures, methods, or a detailed description of the tests you will Conduct (e.g., identity, strength, and purity) The tests provided were limited to analysis and failed to specify and perform at least one test to verify the identity of the active ingredient in the drug batch produced In addition, all retained drug samples containing the component were not tested within the validity period to determine whether they met the established identification and analysis standards Nor does it provide sufficient information about the test procedures, methods, or a detailed description of the tests to be performed (e.g., characteristics, strength, and purity) In response to this letter, provide the following:, used to analyze each lot of your drug products before a lot disposition decision     o An action plan and timelines for conducting full chemical and microbiological testing of retain samples to determine the quality of all batches of drug product distributed to the United States within expiry as of the date of this letter     o A summary of all results obtained from testing retain samples from each batch If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls  • A comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies Based on this review, Provide a detailed plan to remove and evaluate the effectiveness of your laboratory system • your procedure to ensure that any test methods performed by a contract testing laboratory on your own are properly validated before use An action plan and schedule for conducting comprehensive chemical and microbiological testing of retained samples to determine the quality of all batches of drugs sold to the United States during the period of validity from the date of this letter Record a summary of the test results and retain samples from each batch If the drug quality is found to be unqualified, emergency measures shall be taken promptly, such as informing customers and product recall • conduct a comprehensive and independent assessment of laboratory operations, procedures, methods, equipment, documentation and analytical capabilities Based on this review, a detailed plan is provided to improve and evaluate the effectiveness of the laboratory system • ensure that any test methods performed by third-party test laboratories are properly validated prior to use 2 Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84 (d) (1)) You failed to test including components used to manufacture your drug products to determine their identity For example, your first did not ensure that at least one specific identity test was conducted for each lot of active ingredients (b) (4)   In your response, you stated that you revised the specifications for incoming active ingredients (e.g., (b)(4)) to include an identification test You also provided an example of the revised specification sheet for (b)(4), In addition to an example of a third party laboratory test report for the (b) (4) content in (b) (4) lot of (b) (4) raw material In addition to the third-party laboratory test reports on the content of certain ingredients in certain batches of certain raw materials, an example of the revised specification table of this ingredient is also provided   Your response is inadequate You failed to specify and perform at least one test to verify the identity of all of the components you use to manufacture your drug products Further, You failed to test your retain samples of active recipients used in the manufacture of drug products to determine whether they met established specifications for identity Because at least one test could not be specified and performed to verify all ingredients used to manufacture pharmaceutical products In addition, samples of active ingredients retained for drug production were not tested to determine whether they met the criteria In response to this letter, provide the following: API retain samples to determine the quality of all batches of active ingredients used in the manufacture of drug products distributed to the United States within expiry     o A summary of all results obtained from testing API retain samples from each batch If such testing reveals substandard quality drug substances, take rapid corrective actions, such as notifying customers and product recalls   • A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity If you intend to accept any results from your supplier's Certificates of Analysis (COA) instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier's results through initial validation as well as periodic re-validation In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot   • A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer Include your standard operating procedure (SOP) that describes this COA validation program   • A Summary of your program for qualifying and overflowing contract facilities that test the drugs you manufacture