# FDA 483 - Liuzhou Liangmianzhen (LMZ) Co., Ltd. - March 22, 2024

Source: https://www.keypedia.com/records/483/liuzhou-liangmianzhen-lmz-co-ltd/42f89d70-0ff7-4ce2-879e-60477fef518a

> FDA 483 for Liuzhou Liangmianzhen (LMZ) Co., Ltd. on March 22, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Liuzhou Liangmianzhen (LMZ) Co., Ltd.
- Inspection Date: 2024-03-22
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: During an FDA inspection conducted from March 18-22, 2024, at Liuzhou Liangmianzhen (LMZ) Co., LTD., an OTC Drug Manufacturer in Liuzhou, Guangxi, China, several significant observations were noted, indicating deficiencies in compliance with regulatory standards. The inspection identified four main areas of concern. Firstly, the company's laboratory controls were found to be inadequate. Issues included the absence of growth promotion testing for microbiological media, lack of negative controls for microbial samples, and insufficient temperature monitoring for incubators and stability chambers. Furthermore, the firm failed to track or trend microbial testing results. Secondly, equipment cleaning, maintenance, and sanitation practices were deficient. The water system exhibited dead legs and leaks, and cleaning validation for equipment used insufficient sampling. Standing water was observed in cleaned equipment, and the water system components lacked proper identification, with the distribution loop not operating continuously. Thirdly, procedures to prevent objectionable microorganisms in non-sterile drug products were inadequate, as samples were not collected from critical points of use. Lastly, poor lighting conditions were observed in the water system area, hindering proper inspection. These observations, detailed in the FDA Form 483, require the firm to address and implement corrective actions to ensure compliance with Current Good Manufacturing Practices (CGMP) and prevent the distribution of adulterated drug products.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/marvin-d-jones/3101a8da-f5c1-4e0c-b4b1-b09be181be36)
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Company: https://www.keypedia.com/companies/liuzhou-liangmianzhen-lmz-co-ltd/65235d99-a657-42fc-a43b-469f3c722a68

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa