# FDA 483 - APARNA ORGANICS LIMITED - September 11, 2023

Source: https://www.globalkeysolutions.net/records/483/aparna-organics-limited/2f68d350-68f3-40c7-a3c7-e442203e9554

> FDA 483 for APARNA ORGANICS LIMITED on September 11, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: APARNA ORGANICS LIMITED
- Inspection Date: 2023-09-11
- Product Type: drugs
- Office Name: Office of Pharmaceutical Quality Operations
- Summary: Aparna Organics Limited, an Intermediate API Manufacturer in Chilivalasa, India, received a Form 483 with repeat observations concerning significant quality system deficiencies. The inspection revealed inadequate equipment cleaning, a lack of quality unit oversight, and insufficient controls over electronic GMP data. These issues indicate a moderate level of severity regarding the firm's adherence to good manufacturing practices.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/guerlain-ulysse/aeef6f71-43b1-4116-b563-8bb3f2966d6a)

Company: https://www.globalkeysolutions.net/companies/aparna-organics-limited/490be972-8080-4d97-a1f7-a704853a0323

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