# FDA 483 - Indiana Botanic Gardens, Inc - September 30, 2025

Source: https://www.keypedia.com/records/483/indiana-botanic-gardens-inc/d5b1c3cb-9500-41d7-b577-da7060cd781e

> FDA 483 for Indiana Botanic Gardens, Inc on September 30, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Indiana Botanic Gardens, Inc
- Inspection Date: 2025-09-30
- Product Type: drugs
- Office Name: Detroit District Office
- Summary: Indiana Botanic Gardens, Inc. in Hobart, IN, an OTC drug manufacturer, was cited with two observations during an FDA inspection. The inspection revealed deficiencies in following written production and process control procedures, specifically concerning inconsistent mixing times for an OTC product without proper validation. Additionally, the firm failed to store drug products under appropriate conditions, leading to inadequate segregation of expired and cosmetic products from those undergoing stability testing.

## Related Documents

- [483 - 2025-09-30](https://www.keypedia.com/records/483/indiana-botanic-gardens-inc/fff1a0cd-b32a-4fd2-a7c5-6f73c7f3d570)

## Related Officers

- [Tomika L. Crafter](https://www.keypedia.com/people/tomika-l-crafter/6c8260a0-c026-496d-80f6-9c30877e8f52)

Company: https://www.keypedia.com/companies/indiana-botanic-gardens-inc/f8ceaacc-916d-4a7d-9ff8-d86877f74922

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03