# FDA 483 - Kumar Organic Products Ltd. - February 04, 2019

Source: https://www.globalkeysolutions.net/records/483/kumar-organic-products-ltd/b617b9ff-1ca7-4dc1-a0c4-c14536e79d6c

> FDA 483 for Kumar Organic Products Ltd. on February 04, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kumar Organic Products Ltd.
- Inspection Date: 2019-02-04
- Product Type: drugs
- Office Name: FDA District Office — Rockville, Unknown
- Summary: Kumar Organic Products Ltd. in Bangalore, India, received a Form 483 with four observations during an inspection of their Active Pharmaceutical Ingredient (API) manufacturing facility. The inspection revealed significant issues including inadequate investigations into out-of-specification batches, deficiencies in cleaning validation, insufficient cleaning procedures for critical rooms, and a failure to follow written procedures for annual product quality reviews. These findings indicate a lack of robust quality control and adherence to established protocols.

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## Related Officers

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Company: https://www.globalkeysolutions.net/companies/kumar-organic-products-ltd/acc61a81-a684-4eb3-a4c8-d487dc0164e5

Office: https://www.globalkeysolutions.net/offices/fda-district-office-rockville-unknown/3f2f9dd1-d5cc-46db-8426-bd57134d34b7