FDA says it found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.
Based on FDA review, the company’s products, Antibacterial Wet Wipes (in four separate package configurations) are also misbranded under section 502(x) of the FD&C Act, 21 U.S.C. 352(x). Introduction of such products into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
The inspection found that the company did not test its over-the-counter (OTC) finished drug products to determine whether each batch meets identity and strength specifications before releasing those products to the U.S. market.
In addition, the firm lacked reliable testing for microbial attributes. For example, FDA said the company did not have an adequate program for growth promotion testing of media used for microbial testing.
FDA said that that in its response, the firm stated that it will send each finished product batch to a third party to test for active ingredient identity and strength prior to release, and that it also stated plans to purchase a chromatographic analyzer.
“We acknowledge your commitment to perform growth promotion test on each batch of media to assure the reliability of the microbiological results,” penned FDA in its letter. However it said,the response is “inadequate because it did not commit to take any corrective action for products already in the market, include information about your third-party testing laboratory, or provide procedures to be used for additional testing. You must ensure each batch of your drug products meets all chemical and microbiological specifications before release.”
FDA has asked the firm provide:
· A list of all chemical and microbial test methods and specifications used to analyze each batch of your drug products before making the batch disposition decision, and associated written procedures.
· A summary of test results obtained from retrospective testing of retain samples of all drug product batches currently in distribution in the United States. 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 action you will take, such as customer notifications and product recalls.
· A comprehensive and independent review of your laboratory practices, procedures, methods, equipment and analyst competencies. 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 CAPA.
· Provide your procedure to assure that any test methods performed by a contract testing laboratory on your behalf are properly transferred and validated before use.
Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. We also recommend that the qualified consultant perform a comprehensive audit of your entire operation for CGMP compliance and that the consultant evaluates the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.
Antibacterial Wet Wipes are “drugs” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease and/or as defined under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body. Specifically, these products are intended as consumer antiseptic rubs.
FDA placed the company on Import Alert 66-40 on April 12, 2019.
Until Xi’an Livingbond Nonwoven Products Corp correct sall violations completely and FDA confirms compliance with CGMP, the agency may withhold approval of any new applications or supplements listing your firm as a drug manufacturer.