# ASPIRO PHARMA SPECIALITIES PRIVATE LIMITED – FDA 483, Jun 16, 2026

Source: https://www.keypedia.com/records/483/aspiro-pharma-specialities-private-limited/7829761b-57ed-4317-9186-8f975b54f1a3

> FDA 483 for ASPIRO PHARMA SPECIALITIES PRIVATE LIMITED on June 16, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ASPIRO PHARMA SPECIALITIES PRIVATE LIMITED
- Inspection Date: 2026-06-16
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Aspire Pharma Specialities Private Limited, a sterile drug manufacturer in Karkapatla, India, received a Form 483 citing significant deficiencies in their manufacturing processes. Observations included inadequate aseptic process validation, deficient equipment maintenance in aseptic areas, and a systemic failure to investigate discrepancies and manage alarms effectively. These issues raise serious concerns about the quality and sterility assurance of their drug products.

## Related Officers

- [Crystal Monroy](https://www.keypedia.com/people/crystal-monroy/b0414886-fb71-4f35-a453-0ad2baf13bfc)
- [Carolina D. Vasquez](https://www.keypedia.com/people/carolina-d-vasquez/ffa9d542-e660-4575-831e-f11a2de4b978)

Company: https://www.keypedia.com/companies/aspiro-pharma-specialities-private-limited/a4d472c8-2ac6-494c-b6c4-8d4d6746a7c3

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8