Mr. Nageswara Rao Gupta Manepalli
Managing Director/CEO
MMC Healthcare Ltd.
34-B Sidco Industrial Estate
Thirumazhisai, Chennai 600124
Tamil Nadu
India
ceo@mmchealthcareltd.comFEI 3014773352Issued Sep 24, 2024Center 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 3014773352.
Violations3
Issue DateSep 24, 2024
Product TypeDrugs
StatusOpen
Letter Details
Firm
MMC Healthcare Ltd.
Location
Mr. Nageswara Rao Gupta Manepalli
Managing Director/CEO
MMC Healthcare Ltd.
34-B Sidco Industrial Estate
Thirumazhisai, Chennai 600124
Tamil Nadu
India
ceo@mmchealthcareltd.com
FEI Number
3014773352
Country
India
Issue Date
September 24, 2024
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
MMC Healthcare Ltd., a drug manufacturer in India, was cited for significant Current Good Manufacturing Practice (CGMP) violations in finished pharmaceuticals. FDA inspectors found that the company failed to establish an adequate quality control unit and discovered that process validation reports for tablets and capsules contained backdated signatures, added data, and replaced pages, with multiple managers admitting to participating in these practices. The violations rendered the company's drug products adulterated under federal law, as their manufacturing methods, facilities, and controls did not conform to required standards.
MMC Healthcare Ltd. FDA Warning Letter, September 24, 2024
Talk to a Specialist