# FDA 483 - Steriscience Specialties Private Limited - August 19, 2013

Source: https://www.globalkeysolutions.net/records/483/steriscience-specialties-private-limited/55cf68ce-65d3-4c02-81ae-e0f948e32ce6

> FDA 483 for Steriscience Specialties Private Limited on August 19, 2013. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Steriscience Specialties Private Limited
- Inspection Date: 2013-08-19
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Agila Specialities Pvt Ltd, Beta Lactam Division, in Bangalore, India, revealed significant deficiencies in manufacturing practices. Observations included inadequate record-keeping for vial labeling and API reconciliation, as well as issues with process validation for drug products. Additionally, unnecessary activities were noted during the fill line assembly, indicating potential operational inefficiencies and quality control concerns.

## Related Documents

- [483 - 2015-09-01](https://www.globalkeysolutions.net/records/483/steriscience-specialties-private-limited/c8fff591-e664-4a7e-a4df-98d9625de10a)
- [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/regina-t-brown/6e2de1b6-3e5d-40ec-8823-7f0aef908b2b)

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