# FDA 483 - Nosch Labs Private Ltd - September 13, 2024

Source: https://www.globalkeysolutions.net/records/483/nosch-labs-private-ltd/79ded235-3393-4614-8beb-54e9944b6509

> FDA 483 for Nosch Labs Private Ltd on September 13, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nosch Labs Private Ltd
- Inspection Date: 2024-09-13
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Nosch Labs Private Limited, an Active Pharmaceutical Ingredient Manufacturer in Veliminedu, Chityal, Telangana, India, revealed significant deficiencies in quality control and manufacturing processes. Observations included inadequate controls on testing equipment, use of unqualified reference standards, unvalidated analytical methods, irreproducible process validation, and unsound sampling plans for water. The firm also failed to properly evaluate returned products.

## Related Officers

- [Lata C. Mathew](https://www.globalkeysolutions.net/people/lata-c-mathew/0610a0ef-dcc5-43e7-ab74-2ac54d758beb)
- [Investigator ](https://www.globalkeysolutions.net/people/logan-t-williams/a1febf59-970a-4e4e-9c0c-f4ad385582d7)

Company: https://www.globalkeysolutions.net/companies/nosch-labs-private-ltd/f420be04-474e-4f5e-b00a-051b81571637

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8