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

Source: https://www.globalkeysolutions.net/records/483/be-pharmaceuticals-private-ltd/e397dc36-949c-4002-8381-db4e30258acf

> 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: Office of Inspections and Investigations
- Summary: This FDA Form 483 report details significant data integrity and quality control failures at Akorn India PVT, a sterile drug product manufacturer in Paonta Sahib, India. Inspectors found widespread falsification of laboratory testing records for sterility, water analysis, environmental monitoring, biological indicators, bioburden, bacterial endotoxins, and media fills. Additionally, the firm exhibited inadequate personnel training, poor change control, uninvestigated discrepancies, and deficiencies in laboratory controls, facility design, document control, warehousing, and equipment cleaning.

## Related Documents

- [483 - 2014-06-12](https://www.globalkeysolutions.net/records/483/be-pharmaceuticals-private-ltd/bfb5afab-8c85-4562-a18d-f514856ed78d)
- [483 - 2023-07-07](https://www.globalkeysolutions.net/records/483/be-pharmaceuticals-private-ltd/9be9667e-7c5c-4308-af25-89856e7b9204)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/parul-m-patel/2a7e7ff1-6b9b-42d7-8bc4-03eeecc5cecc)
- [President](https://www.globalkeysolutions.net/people/peter-e-baker/c32eb848-de28-4725-80c9-ef8548d445bf)

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

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8