# FDA 483 - Makson Health Care Private Ltd. - September 29, 2022

Source: https://www.keypedia.com/records/483/makson-health-care-private-ltd/146f2daf-269d-46e8-aeb6-1919d3843fdf

> FDA 483 for Makson Health Care Private Ltd. on September 29, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Makson Health Care Private Ltd.
- Inspection Date: 2022-09-29
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Makson Health Care Private Ltd. in Anharam, Telangana, India, an OTC drug manufacturer, was cited with seven observations during an FDA inspection. The inspection revealed significant deficiencies across quality control, complaint handling, laboratory controls, and facility management, indicating a lack of adherence to established procedures and good documentation practices. Issues included inadequate supplier oversight, destroyed training records, unvalidated test methods, and improper storage conditions, suggesting a systemic breakdown in quality assurance.

## Related Officers

- [Bruce A. Mcguckin](https://www.keypedia.com/people/bruce-a-mcguckin/7fb39eba-c4d2-48c0-9360-9323e5213650)
- [Investigator](https://www.keypedia.com/people/guerlain-ulysse/aeef6f71-43b1-4116-b563-8bb3f2966d6a)

Company: https://www.keypedia.com/companies/makson-health-care-private-ltd/35ca0e10-d4f7-4d3c-bba5-ac4db7f3c658

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1