# FDA 483 - K Patel Phyto Extractions Private Ltd - April 28, 2023

Source: https://www.globalkeysolutions.net/records/483/k-patel-phyto-extractions-private-ltd/4e34e9f5-9d1c-4297-a4aa-bb1f57911b81

> FDA 483 for K Patel Phyto Extractions Private Ltd on April 28, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: K Patel Phyto Extractions Private Ltd
- Inspection Date: 2023-04-28
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of K Patel Phyto Extractions Pvt Ltd, an API (Intermediate) Manufacturer, identified deficiencies in the firm's investigation processes. The observations highlight inadequate root cause analysis for Out of Specification (OOS) results and incomplete documentation for laboratory incident reports. These issues indicate a lack of thoroughness in addressing unexplained discrepancies and their potential impact.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/rachael-oyewole/bc642edb-4124-4cd1-b979-0d752ead1bfd)

Company: https://www.globalkeysolutions.net/companies/k-patel-phyto-extractions-private-ltd/bbf009f3-31f6-4e6e-a120-33a1b50293cf

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd