# FDA 483 - Amol Pharmaceuticals Private Ltd. - September 13, 2019

Source: https://www.globalkeysolutions.net/records/483/amol-pharmaceuticals-private-ltd/8f659989-65ba-4ca7-8948-2d401528d448

> FDA 483 for Amol Pharmaceuticals Private Ltd. on September 13, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amol Pharmaceuticals Private Ltd.
- Inspection Date: 2019-09-13
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Amol Pharmaceuticals Private Ltd., an OTC drug product manufacturer in Sanganer, Jaipur, India, was cited for significant deficiencies in its production and process controls. The inspection revealed a lack of written procedures, unestablished process parameters for US marketed products, and a deficient hold time study. These issues raise concerns about the identity, strength, quality, and purity of their drug products.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/unnee-ranjan/43f1d07e-4079-4d33-88a9-baf6a5df932c)

Company: https://www.globalkeysolutions.net/companies/amol-pharmaceuticals-private-ltd/25109535-73e8-434b-98f1-01695cc33434

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