# FDA 483 - Yash Pharmaceuticals - September 03, 2019

Source: https://www.keypedia.com/records/483/yash-pharmaceuticals/ed7b0af2-c8e1-49b8-b8bb-6aa85826bfea

> FDA 483 for Yash Pharmaceuticals on September 03, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Yash Pharmaceuticals
- Inspection Date: 2019-09-03
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Yash Pharmaceuticals, an OTC drug products manufacturer in Roorkee, India, was cited for significant deficiencies across its quality control, manufacturing, and laboratory operations. Observations included inadequate laboratory controls for product specifications and testing, lack of appropriate stability data for expiration dates, and failure to use tamper-evident packaging. Additionally, the firm had unvalidated and insufficient cleaning procedures, unqualified filling equipment, poor equipment maintenance, unsecured label storage, and a deficient quality control unit that failed to follow or adequately establish critical procedures.

## Related Documents

- [483 - 2024-12-06](https://www.keypedia.com/records/483/yash-pharmaceuticals/0ee755f7-ba82-4198-adfa-a26bf638d995)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/rajiv-r-srivastava/05b42bfd-0cf4-42ce-89e1-b81bf36eaa17)
- [Letitia Robinson](https://www.keypedia.com/people/letitia-robinson/b1711f89-fb25-4a36-a288-efe7c8a301c5)

Company: https://www.keypedia.com/companies/yash-pharmaceuticals/8a23710a-5e5e-417e-b73d-53e308a60143

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