# FDA 483 - Goran Pharma Private Ltd - November 15, 2017

Source: https://www.keypedia.com/records/483/goran-pharma-private-ltd/634a1387-a1d6-46b2-a06d-856cd962357e

> FDA 483 for Goran Pharma Private Ltd on November 15, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Goran Pharma Private Ltd
- Inspection Date: 2017-11-15
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: During an FDA inspection conducted from November 13-15, 2017, Goran Pharma Pvt Ltd, a drug manufacturer in Sihor, Gujarat, India, received a Form FDA 483 outlining significant observations related to their adherence to Current Good Manufacturing Practices (cGMP). The findings indicate a comprehensive breakdown in quality control and production systems.Key issues included a severely inadequate microbiology laboratory lacking separate facilities for live organisms, proper sterilization documentation and verification, and essential growth promotion testing. Personnel were observed wearing inappropriate attire, and critical equipment surfaces showed damage, both being repeat observations. The company failed to follow its own written procedures, such as reusing packaging materials after manual alteration, and exhibited deficiencies in annual product quality reviews and employee cGMP training.Further concerns involved an inadequate water purification system susceptible to microbial contamination, and a lack of proper qualification for component suppliers. Laboratory controls were deemed unsound, with products released before complete testing, non-USP test methods used without validation, and poor general laboratory practices. Stability studies and reserve sample programs were also found to be deficient, impacting product expiration dating and quality assurance. The FDA requires Goran Pharma Pvt Ltd to address these observations by implementing comprehensive corrective and preventive actions to ensure compliance with regulatory standards for drug manufacturing.

## Related Documents

- [483 - 2017-11-15](https://www.keypedia.com/records/483/goran-pharma-private-ltd/db4984d7-0722-4b5d-818c-ff968df6d211)

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Company: https://www.keypedia.com/companies/goran-pharma-private-ltd/266ed4ed-cf97-41cb-9979-f885ffb2f7e7

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c