# FDA 483 - FLOWCHEM PHARMA PRIVATE LIMITED - September 12, 2025

Source: https://www.globalkeysolutions.net/records/483/flowchem-pharma-private-limited/a625d5e7-99c2-4daf-afda-da497219813c

> FDA 483 for FLOWCHEM PHARMA PRIVATE LIMITED on September 12, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FLOWCHEM PHARMA PRIVATE LIMITED
- Inspection Date: 2025-09-12
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Flowchem Pharma Private Limited, a drug substance manufacturer in Hindupur Taluk, India, was inspected by the FDA from September 8-12, 2025. The inspection revealed significant deficiencies across multiple areas, including inadequate equipment maintenance, unvalidated analytical methods, deficient specifications, improperly qualified standards, incomplete batch records, inadequate process validation, and improper material storage. These issues indicate a broad lack of control over manufacturing processes and quality, suggesting a high severity of non-compliance with GMP regulations.

## Related Documents

- [WARNING_LETTER - 2025-09-12](https://www.globalkeysolutions.net/records/warning_letter/flowchem-pharma-private-limited/467186e9-0235-4084-a8db-51503e716208)

## Related Officers

- [Joseph A. Piechocki](https://www.globalkeysolutions.net/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)
- [Pearl C. Ozuruigbo](https://www.globalkeysolutions.net/people/pearl-c-ozuruigbo/28ec383e-a602-4764-8d14-20b1049f93d7)

Company: https://www.globalkeysolutions.net/companies/flowchem-pharma-private-limited/e673da78-5396-4545-a505-e5b6f7f4d1ba

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