Another Chinese pharmaceutical company was warned by the FDA

According to Yao Zhi's news reporter, Henan Kangdi Medical Equipment Co., Ltd received a warning letter from FDA on December 3, 2019 Henan Kangdi Medical Equipment Co., Ltd is a manufacturer specializing in plaster, patch and other medical equipment products The letter pointed out that the company's sales of capsicum plaster hot and first MedX patch with 4% lidocaine in the United States were not approved by FDA, and the raw materials for the production of drugs were not strictly regulated Recently, the full text of the warning letter was posted on the FDA website The warning letter posted on the FDA website is as follows: December 3, 2019 warning letter 320-20-09 Dear Mr Qi Lei: the U.S Food and Drug Administration (FDA) inspected your drug manufacturing facility, Henan Kangdi Medical Devices Co Ltd., 3009271465, at SME Pioneer Park, No 4, 2nd area, Zhoukou, Henan, from March 4 to 7, 2019 The US Food and Drug Administration (FDA) inspected Henan Kangdi Pharmaceutical Machinery Co., Ltd from March 4 to 7, 2019 This warning letter summarizes significant violations of current good manufacturing practice (CGMP) Regulations for finished pharmaceuticals See 21 CFR, parts 210 and 211 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)   Your firm manufactures "Capsicum Plaster HOT" and " 1st Medx-Patch With 4% Lidocaine." These products are unapproved new drugs in violation of section 505(a) of the FD&C Act, 21 U.S.C 355(a) Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C 331(d) These violations are described in more detail below These products are unapproved new drugs and violate the FD & C act Under the code, the introduction of such products into the United States market is prohibited These violations are described in more detail below We reviewed your March 22, 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 manufactures and distributes various over-the-counter (OTC) transdermal patch drug products such as "Capsicum Plaster HOT" pain relieving and " (b)(4) for the United States market Our inspection found that you did not test your finished drug products to determine whether each batch met identity and strength specifications before Being released to the U.S market Complete testing of each batch before release is an essential part of determining if a drug product batch measures its specifications FDA inspection found that the company did not inspect the finished product before it was put on the U.S market to determine whether each batch of product meets the characteristics and strength specifications The complete test of each batch of drugs before release is an important step to determine whether a batch of drugs meet the specifications   The quality unit must be empowered to make final quality decisions It is essential that the quality unit be enabled to provide timely oversight of all laboratory and manufacturing data that could impact product quality, whether or not lots have already been distributed When making batch disposition decisions, the quality unit must be provided With all batch production and control records, including all deviations and test data, to enable a fully informed and appropriate decision regulating feasibility for distribution The quality unit must ensure that drug products are fully tested for all critical attributes prior to release Regardless of whether the batch has been sold or not, the quality department must be able to timely supervise all laboratory and production data that may affect product quality When making a batch processing decision, the quality department must provide all batch production and control records, including all deviation and test data, so as to make a fully informed and appropriate decision on whether it is suitable for sale The quality department must ensure that the drug is fully tested for all key attributes before leaving the factory   In your response, you stated that you will search for a third-party testing laboratory with adequate capabilities Additionally, You committed to test for the active interested in each batch of finished drug products sold within the U.S market to ensure product specifications are met In addition, we promise to test the active ingredients in each batch of products sold in the U.S market to ensure that the products conform to the specifications   Your response is inadequate because you did not include information about your third-party testing laboratory including name and location, methods, or a detailed description of the tests they will conduct (e.g., identity, strength and purity) Furthermore, you did not provide how you will evaluate the capability of your third party to perform the intended tests Additionally, You provided no testing documentation for finished drug product batches currently in the U.S market In addition, there are no test documents provided on how to evaluate the ability of third-party laboratories to perform tests and product batches currently on the U.S market In response to this letter, provide: for this letter, please provide: a comprehensive and independent review of your laboratory practices, procedures, methods, equipment, and analytical competences Based on this review, Provide a detailed corrective action and preventive action (CAPA) plan to fully remediate your laboratory system Your plan should also include the procedures you will use to evaluate the effectiveness of the implemented cap a plan Based on this review, a detailed corrective and preventive action (CAPA) plan is provided to completely correct the laboratory test system The plan shall also include procedures to be used to evaluate the effectiveness of the implemented cap a plan A list of all analytical test methods and specifications used to analyze each batch of your drug products before making the batch disposition decision Include associated written procedures Including relevant written procedures   • A summary of test results obtained from retrospective testing of retain samples of all drug product batches currently in distribution in the U.S Include test results for identity and strength of active ingredients, and all other appropriate chemical and microbial quality attributes If you released any batch that was out of specification, indicate the corrective actions you will take, Such as customer notifications and product recalls Provide a timeline for completing this testing rapidly If any out of specification batches are sold, please indicate the corrective actions to be taken, such as customer notification and product recall Provide a schedule for quick completion of tests   • A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture Your summary should include, but not be limited to, your procedure to ensure that any test methods performed by a contract testing laboratory on your behalf are properly validated prior to use for batch analysis Additionally, Include the procedure to evaluate the capability of your third party to achieve the testing they are contracted to perform The summary shall include, but not be limited to, information to ensure that any test methods performed by the cooperative test laboratory on behalf of condi are properly validated prior to being used for batch analysis In addition, it shall also include information to evaluate the third party's ability to complete the tests specified in the contract   2 Your firm failed to conduct at least one test to verify the identity of each component of a drug product Your firm also failed to validate and establish the reliability of your component supplier's test analyses at appropriate intervals (21 CFR 211.84(d)(1) and (2))   Condi failed to perform at least one test to verify the properties of each component of the drug It also failed to verify and determine the reliability of the raw material supplier test analysis within the appropriate time interval   You failed to test incoming active pharmaceutical ingredients (API) and other raw materials (e.g., (b)(4)) used to manufacture your drug products to determine their identity, purity, strength, and other appropriate quality attributes Instead, our investigator observed your firm released API and other materials for use in manufacturing based solely on a visual inspection of the contents of material containers and a review of component suppliers analys