# FDA 483 - MMC HEALTHCARE LTD. - March 30, 2024

Source: https://www.keypedia.com/records/483/mmc-healthcare-ltd/3b9baf26-824e-4b5b-8a32-848ef21eb4c5

> FDA 483 for MMC HEALTHCARE LTD. on March 30, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MMC HEALTHCARE LTD.
- Inspection Date: 2024-03-30
- Product Type: drugs
- Office Name: Food and Drug Administration
- Summary: An FDA inspection conducted from March 25-30, 2024, at MMC HEALTHCARE LTD. in Chennai, India, revealed significant violations of Current Good Manufacturing Practices (cGMPs). The drug manufacturer received an FDA Form 483 listing eight observations, primarily affecting its quality, production, laboratory, and facility systems.Key issues included a severely deficient quality control unit, with the Quality Assurance Manager and other key personnel involved in altering process validation records and backdating signatures for drug products, constituting a major data integrity breach. The firm also failed to investigate out-of-specification assay results in annual product reviews.Production deficiencies encompassed the release and distribution of multiple drug products, such as (b)(4) Granules and various tablets/capsules, without complete or re-validated process validations. Packaging records also lacked adequate procedures for yield determination.Laboratory system observations highlighted the use of a non-validated E. coli test method that deviated from United States Pharmacopeia standards, and a lack of data integrity controls for electronic records, including an absence of audit trails and proper analyst accountability in UV/Vis Spectroscopy and HPLC systems. Certificates of Analysis also failed to document testing methods or comprehensive microbiology results. Additionally, basic facility deficiencies were noted, with washing areas lacking hot water.MMC HEALTHCARE LTD. is required to implement comprehensive corrective actions to address these systemic failures, ensure data integrity, validate processes and test methods, and comply with cGMP regulations to assure the safety, quality, and purity of its drug products.

## Related Documents

- [483 - 2024-03-30](https://www.keypedia.com/records/483/mmc-healthcare-ltd/44176f28-da66-4aed-a15f-40c0264f051f)
- [EIR - 2024-03-30](https://www.keypedia.com/records/eir/mmc-healthcare-ltd/108c520a-d577-4597-986f-ca48d3f699a4)
- [WARNING_LETTER - 2024-03-30](https://www.keypedia.com/records/warning_letter/mmc-healthcare-ltd/cd03b4a1-aab9-4238-bb78-e1dbe207c483)

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