# FDA 483 - BE Pharmaceuticals Private Ltd. - June 12, 2014

Source: https://www.keypedia.com/records/483/be-pharmaceuticals-private-ltd/bfb5afab-8c85-4562-a18d-f514856ed78d

> FDA 483 for BE Pharmaceuticals Private Ltd. on June 12, 2014. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BE Pharmaceuticals Private Ltd.
- Inspection Date: 2014-06-12
- Product Type: drugs
- Office Name: Center for Devices and Radiological Health
- Summary: An FDA inspection of Akorn India PVT, a sterile drug product manufacturer, conducted from June 9-12, 2014, revealed critical deviations from regulatory expectations. The most significant finding involved pervasive data integrity issues, including the falsification of numerous laboratory records. Investigators observed that sterility, water, environmental monitoring, bioburden, bacterial endotoxin, and media fill tests were frequently documented as completed, but the actual samples were never prepared, incubated, or analyzed. In some instances, samples were found missing, or records were altered after initial inspection. Additional violations highlighted a lack of adequate quality control mechanisms. This included a failure to investigate out-of-specification environmental monitoring results, non-adherence to change control procedures for facility expansion, and incorrect practices in personnel monitoring and sterility testing. The inspection also identified an insufficient number of qualified microbiologists and widespread issues with unofficial, incomplete, or pre-filled personnel training records. Furthermore, the facility exhibited inadequate environmental controls, such as compromised airflow in sterile filling areas, improperly located warehouse temperature probes, and the use of unsuitable cleaning wipes. These observations collectively indicate serious non-compliance with current Good Manufacturing Practices (cGMP) for sterile drug product manufacturing. Akorn India PVT is required to implement immediate and comprehensive corrective actions to rectify these systemic issues and ensure product quality and patient safety.

## Related Documents

- [483 - 2014-06-12](https://www.keypedia.com/records/483/be-pharmaceuticals-private-ltd/e397dc36-949c-4002-8381-db4e30258acf)
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## Related Officers

- [investigator](https://www.keypedia.com/people/parul-m-patel/2a7e7ff1-6b9b-42d7-8bc4-03eeecc5cecc)
- [FDA_PERSONNEL](https://www.keypedia.com/people/sanjay-mohan/8196e97c-ee68-495e-b61b-57898114be63)
- [President](https://www.keypedia.com/people/peter-e-baker/c32eb848-de28-4725-80c9-ef8548d445bf)

Company: https://www.keypedia.com/companies/be-pharmaceuticals-private-ltd/31fa5ef8-464e-408a-890d-1a082511d775

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7