# FDA 483 - MICROTROL STERILISATION SERVICES PRIVATE LIMITED - December 19, 2023

Source: https://www.keypedia.com/records/483/microtrol-sterilisation-services-private-limited/d697f7b6-664e-4a6f-9b50-096c1b32ae83

> FDA 483 for MICROTROL STERILISATION SERVICES PRIVATE LIMITED on December 19, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MICROTROL STERILISATION SERVICES PRIVATE LIMITED
- Inspection Date: 2023-12-19
- Product Type: other
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of MICROTROL STERILISATION SERVICES PRIVATE LIMITED, a contract sterilization organization in Gurgaon, Haryana, revealed significant deficiencies across its quality system. The firm lacked a functional quality control unit, exhibited widespread data integrity failures, and failed to adequately validate its sterilization processes. Additionally, issues were noted in laboratory controls and equipment maintenance, indicating a systemic lack of control over drug product sterilization.

## Related Officers

- [Investigator](https://www.keypedia.com/people/kellia-n-hicks/44104c4a-70c1-47fc-9a77-c09c41bacc2b)

Company: https://www.keypedia.com/companies/microtrol-sterilisation-services-private-limited/44b3b68e-6d6d-4ad5-bfb2-cc75234069b2

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