# FDA 483 - Steriscience Specialties Private Limited - September 01, 2015

Source: https://www.globalkeysolutions.net/records/483/steriscience-specialties-private-limited/c8fff591-e664-4a7e-a4df-98d9625de10a

> FDA 483 for Steriscience Specialties Private Limited on September 01, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Steriscience Specialties Private Limited
- Inspection Date: 2015-09-01
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Mylan Laboratories Limited, a sterile drug manufacturer in Bangalore, India, was cited for multiple significant deficiencies during an FDA inspection. Observations included inadequate equipment cleaning and disinfectant qualification, deficiencies in aseptic processing environmental monitoring, incomplete batch production records, and a lack of written procedures for the quality control unit. Additionally, the firm failed to establish proper procedures to prevent objectionable microorganisms in sterile areas and did not follow established stability testing protocols.

## Related Documents

- [483 - 2013-08-19](https://www.globalkeysolutions.net/records/483/steriscience-specialties-private-limited/55cf68ce-65d3-4c02-81ae-e0f948e32ce6)
- [483 - 2019-02-14](https://www.globalkeysolutions.net/records/483/steriscience-specialties-private-limited/8abbc69f-97aa-4f0f-a22d-68df1a7635ab)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/tajah-l-blackburn/27b25d9d-3186-4b3a-a511-2f693d3c889a)
- [Chemist at US Department of Health and Human Services](https://www.globalkeysolutions.net/people/felix-maldonado/d7a5c4bd-2aa7-405f-b3c4-17ef35152ab4)
- [Investigator](https://www.globalkeysolutions.net/people/meisha-r-waters/4345cca4-40e6-44a2-9cd2-ab17418cd26a)

Company: https://www.globalkeysolutions.net/companies/steriscience-specialties-private-limited/975a3188-8291-4516-ab80-57e5e3fed081

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321