# FDA 483 - Synergene Active Ingredients Pvt. Ltd. (Unit II) - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/synergene-active-ingredients-pvt-ltd-unit-ii/5f6682f2-9bdc-4d52-b9bf-13fb37b9548b

> FDA 483 for Synergene Active Ingredients Pvt. Ltd. (Unit II) on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Synergene Active Ingredients Pvt. Ltd. (Unit II)
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Synergene Active Ingredients Pvt Ltd, an API manufacturer in Parawada Mandal, India, revealed significant deficiencies in quality control and manufacturing processes. Observations included inadequate investigations for out-of-specification results and laboratory incidents, insufficient cleaning and sanitization of non-dedicated equipment, and incomplete documentation of critical manufacturing steps. These issues indicate a lack of robust quality systems to ensure product quality and prevent contamination.

## Related Officers

- [Dipesh K. Shah](https://www.globalkeysolutions.net/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)

Company: https://www.globalkeysolutions.net/companies/synergene-active-ingredients-pvt-ltd-unit-ii/76af9fd8-338b-4226-b788-72e90b0e2f0f

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1