# FDA 483 - Intas Pharmaceuticals Limited - February 17, 2017

Source: https://www.globalkeysolutions.net/records/483/intas-pharmaceuticals-limited/7b1a2fd4-c8a7-4787-b726-6d7bd5f27637

> FDA 483 for Intas Pharmaceuticals Limited on February 17, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Intas Pharmaceuticals Limited
- Inspection Date: 2017-02-17
- Product Type: drugs
- Office Name: FDA District Office — Silver Springs, Maryland
- Summary: Intas Pharmaceuticals Limited, an API and drug product manufacturer in Ahmedabad, India, was cited for significant deficiencies during an FDA inspection. Observations included a lack of established written procedures for equipment cleaning and storage, as well as inadequate studies for pre-cleaning and hold times. Additionally, the firm failed to store Active Pharmaceutical Ingredients (API) under recommended temperature conditions, potentially compromising product quality.

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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/intas-pharmaceuticals-limited/0db00702-d7f6-4a8b-87d1-1b32ac236cc8

Office: https://www.globalkeysolutions.net/offices/fda-district-office-silver-springs-maryland/079bb75c-3759-4baa-baed-4159edd64552