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

Yaozhi.com learned that Hubei Bingbing Pharmaceutical (Group) Co., Ltd received a warning letter from FDA on October 3, in which it pointed out that in 2018, due to the relocation of the company, cGMP written data and samples of some batches of drugs produced at the original plant site were lost, and after receiving complaints about these batches of drugs, samples of different batches were used for testing and other problems On November 5, the full text of the warning letter was posted on the FDA website Hubei Bing Bing Pharmaceutical (Group) Co., Ltd., formerly known as Wuhan BINGBING PHARMA, was founded in 2006 It is a modern pharmaceutical company specializing in research and development, production and marketing of hydrogels On August 4, 2011, the company obtained the production approval document of indomethacin cataplasm, which is the first and only approved cataplasm in China On November 5, the warning letter posted on the FDA website was as follows: warning letter 320-20-02 October 3, 2019 Dear Mr Yu: Dear Mr Yu: the U.S Food and Drug Administration (FDA) inspected your drug manufacturing facility, Bing Pharmaceutical (Hubei) Co Ltd., Fei 3014538973, at No 698 Bing Road, Economic Development Zone, Shiyan, Hubei, from May 7 to 10, 2019 This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals See 21 CFR, parts 210 and 211 … Translation.. The US Food and Drug Administration (FDA) inspected Hubei Bingbing Pharmaceutical (Group) Co., Ltd from May 7 to 10, 2019 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) … Translation.. Because your methods, facilities, manufacturing processes, packaging, or storage methods do not comply with CGMP regulations, your 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 May 31, 2019, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence … Translation.. We have reviewed your response to FDA form 483 on May 31, 2019 in detail and confirm your subsequent response During our inspection, our investigator observed specific violations including, but not limited to, the following … Translation.. During the inspection, the specific violations found by our inspectors include but are not limited to the following 1 Your firm failed to maintain written production, control, or distribution records specifically associated with a batch of a drug product for at least one year after the expiration date of the batch (21 CFR 211.180(a)) … Translation.. Your company has failed to maintain a written record of production, control or distribution of a batch of drugs for at least one year after the expiration of the batch (21 CFR 211.180 (a)) You manufactured drugs at your Wuhan facility at Building (b)(4), No 5, Kangda Street, Longyang Avenue, Hanyang District, Wuhan, and then transferred drug production to your Hubei facility and closed the Wuhan facility Your firm failed to maintain manufacturing records, raw material and finished product testing records, retain samples, stability samples, and other CGMP records for your over-the-counter (OTC) (b)(4) drug products manufactured at your Wuhan facility During the inspection at the Hubei facility, you stated that you lost CGMP manufacturing documentation and drug product samples during the transfer of your manufacturing facility from Wuhan to Hubei in May 2018 … Translation.. You produced drugs in the Wuhan factory, building 5, Kangda street, Longyang Avenue, Hanyang District, Wuhan City, and then transferred the drug production to the Hubei factory and closed the Wuhan factory However, production records, raw material and finished product test records, samples, stability samples and other cGMP records were not kept for OTC produced by Wuhan factory During the factory inspection in Hubei, you stated that you lost the cGMP production documents and drug samples during your transfer from Wuhan to Hubei in May 2018 In your response, you stated that you initiated an investigation to assess the scope of impacted product, will attempt to collect samples from the market to evaluate and take “all mandatory and necessary measures, ” and will conduct a quality system evaluation using a third-party consultant Your response is inadequate because you failed to appropriately address the impact of missing records and samples on drug products already on the market Maintaining all manufacturing and testing records, as well as representative product samples, is critical to establish that your products meet their required quality attributes … Translation.. In your reply, it is stated that you have launched a survey to assess the scope of the affected products, will try to collect samples from the market for evaluation and take "all mandatory and necessary measures", and will use a third-party consultant for quality system evaluation Your response is inadequate because the impact of missing records and samples on the drugs already on the market has not been properly addressed Maintenance of all production and test records, as well as representative product samples, is essential to determine that the product meets the required quality attributes In response to this letter, provide: … Translation.. For this letter, please provide: · a complete, independent assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient Include a detailed corrective action and preventive action (CAPA) plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation … Translation.. A complete and independent assessment of the file system used throughout the production and laboratory operations to identify deficiencies in the record specification Include detailed corrective and preventive action (CAPA) plan, and comprehensively correct the company's document record specification, so as to ensure that the company retains attributable, clear, complete, original, accurate and contemporaneous records throughout the operation process · A detailed risk assessment of drug products on the market without any manufacturing documentation and without retains or stability samples to support investigations and expiration dating Specify actions, with timelines, that you will take in response to the risk assessment, such as customer notifications and initiating recalls … Translation.. Detailed risk assessment shall be carried out for drugs without production documents and samples on the market to support investigation and determination of validity period Specify actions to be taken for risk assessment, such as customer notification and recall initiation 2 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)) … Translation.. You have failed to perform appropriate laboratory tests on each batch to determine whether it meets the final specification of the drug (including the characteristics and strength of each active ingredient) Your firm released OTC drug products to the United States market without testing the identity and strength of each active ingredient For example, your firm failed to test for the active ingredients, (b)(4), in your (b)(4)products Testing is essential to ensuring that the drug products you manufacture meet established specifications for the required chemical attributes … Translation.. Your company's over-the-counter drug products on the U.S market do not test the characteristics and strength of each active ingredient For example, they do not test the active ingredient in the product Testing is essential to ensure that your product meets the specifications for the required chemical properties We acknowledge your commitment to discontinue the manufacture and distribution of (b)(4) products until analytical methods for (b)(4) active ingredients have been established and validated or verified However, your response is inadequate You failed to provide details for establishing that your OTC drug products in distribution meet their specifications … Translation.. We have received your commitment to stop the production and sale of products before the establishment, validation or validation of the active ingredient analysis method However, your response is insufficient and you did not provide detailed information to prove that your over-the-counter drug product meets the specifications In response to this letter, provide a list of chemical and microbial specifications, including test methods, used to analyze each lot of your drug products before a lot disposition decision The list should include: … Translation.. For this letter, you need to provide a list of chemical and microbiological specifications, including test methods, to analyze each batch of drugs, and then make a batch disposal decision The list should include: 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 Translation.. 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 in the United States for the period of validity from the date of this letter 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 … Translation.. A summary of all results obtained from the test, retaining samples from each batch If the drug quality is found to be unqualified, measures shall be taken promptly, such as informing customers and product recall 3 Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22) … Translation.. Your company's quality control department failed to fulfill its responsibilities to ensure that the drugs produced meet the requirements of cGMP and meet the specified specifications of characteristics, strength, quality and purity During the inspection, our investigator observed that your quality unit (QU) did not provide adequate oversight for the manufacture of your OTC (b)(4) For example, yo