Mr. Yanzhuan Zheng
Owner/President
Bio-Medical Pharmaceutical Manufacturing Corporation
4311 South Drive
Houston , TX 77053
United StatesFEI 1650090Issued Feb 5, 2026Center for Drug Evaluation and Research (CDER)
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 1650090.
Mr. Yanzhuan Zheng
Owner/President
Bio-Medical Pharmaceutical Manufacturing Corporation
4311 South Drive
Houston , TX 77053
United States
FEI Number
1650090
Country
United States
Issue Date
February 05, 2026
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
Bio-Medical Pharmaceutical Manufacturing Corporation was found to be manufacturing adulterated over-the-counter drugs due to significant violations of Current Good Manufacturing Practice (CGMP) regulations during an FDA inspection in August 2025. The facility failed to establish proper written procedures to prevent microbiological contamination of sterile drug products, including inadequate validation of aseptic and sterilization processes, and lacked separate or defined areas with appropriate controls to prevent contamination in aseptic processing areas. Additionally, the company failed to fulfill its drug listing obligations under federal regulations, a violation prohibited under the FD&C Act.
Bio-Medical Pharmaceutical Manufacturing Corporation FDA Warning Letter, February 5, 2026
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