# FDA 483 - Kreative Organics Private Limited - February 07, 2020

Source: https://www.keypedia.com/records/483/kreative-organics-private-limited/f59c7849-6886-4ec6-8200-40281b635fbe

> FDA 483 for Kreative Organics Private Limited on February 07, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kreative Organics Private Limited
- Inspection Date: 2020-02-07
- Product Type: drugs
- Office Name: Office of Pharmaceutical Quality Operations
- Summary: An FDA inspection of Innovative Organics Private Limited in Hyderabad, India, revealed significant quality control deficiencies. The firm released an API batch potentially contaminated with glass particulates to the American market and failed to conduct thorough investigations into deviations and out-of-specification results. Additionally, the Quality Control Unit maintained incomplete procedures, lacked proper system access controls, and had issues with equipment calibration and stability studies.

## Related Documents

- [483 - 2025-05-02](https://www.keypedia.com/records/483/kreative-organics-private-limited/433ca762-8d2e-4ad9-aa3f-da0b0352fc58)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/darren-s-brown/389a4d1f-7f34-42cd-bdc8-5bebd41aff56)
- [Jose R. Lopez](https://www.keypedia.com/people/jose-r-lopez/f4e8e5fa-4765-4d8b-828d-32c202f8dadc)

Company: https://www.keypedia.com/companies/kreative-organics-private-limited/a7ac8ac3-c335-4d67-ba2d-5cdc59181996

Office: https://www.keypedia.com/offices/office-of-pharmaceutical-quality-operations/6b0153a9-c1d1-46a5-8b10-836d2ae44ffe