# FDA 483 - Shree Mahadev Intermediate - February 07, 2019

Source: https://www.globalkeysolutions.net/records/483/shree-mahadev-intermediate/737aec1d-790c-4c67-909a-71ab147a209d

> FDA 483 for Shree Mahadev Intermediate on February 07, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shree Mahadev Intermediate
- Inspection Date: 2019-02-07
- Product Type: drugs
- Office Name: FDA District Office — Industry Information, www.fda.gov/oc/industry
- Summary: An FDA inspection of Shree Mahadev Intermediate in Ankleshwar, India, from February 5-7, 2019, resulted in a Form 483 with 10 observations. The firm demonstrated significant deficiencies across its quality systems, including a lack of written procedures, inadequate record keeping, insufficient employee training, and poor equipment and facility maintenance. These issues indicate a broad failure to comply with current good manufacturing practices for intermediate product manufacturing.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/kellia-n-hicks/44104c4a-70c1-47fc-9a77-c09c41bacc2b)

Company: https://www.globalkeysolutions.net/companies/shree-mahadev-intermediate/91eca54d-c3f8-4f1f-92b1-e8ee0b2ad170

Office: https://www.globalkeysolutions.net/offices/fda-district-office-industry-information-wwwfdagovocindustry/39d0b02a-2d01-4055-b103-a21b1d431c15