# FDA 483 - bhaumik diversified llc  - November 03, 2021

Source: https://www.keypedia.com/records/483/bhaumik-diversified-llc/da29d2f2-e338-4d41-b845-98f477c939e3

> FDA 483 for bhaumik diversified llc  on November 03, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: bhaumik diversified llc 
- Inspection Date: 2021-11-03
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: The FDA Form 483 details multiple observations from an inspection of a facility producing sterile and non-sterile drug products, including hazardous and potent drugs like hormones (Testosterone, Progesterone).

Key violations include inadequate segregation and cleaning of utensils to prevent cross-contamination of hazardous/potent drugs due to a lack of dedicated rooms, hoods, or equipment. Smoke studies were found inadequate, failing to demonstrate unidirectional airflow. Media fills did not simulate worst-case aseptic production conditions, with examples of high-volume sterile injectable batches (e.g., Kisspeptin-10, Glutathione, Nandrolone Decanoate) not being adequately represented.

Disinfection practices were insufficient; a sterile technician failed to meet the required 4-minute contact time for a sporicidal solution (b)(4) (Clostridium difficile spores require 4 minutes, but only 2 minutes were used), and no timer was available. Non-sterile (b)(4) was used in ISO-classified areas, with the sterile bottle compromised by removing the spray head and leaving it partially open. Non-sterile scissors and (b)(4) were used and stored exposed in the ISO7 buffer room during sterile drug production. Personnel failed to disinfect or change gloves after touching a garbage can before handling supplies and entering the ISO5 BSC.

The facility used non-pharmaceutical grade components (e.g., (b)(4), (b)(4), (b)(4)) in sterile

## Related Officers

- [Investigator](https://www.keypedia.com/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)

Company: https://www.keypedia.com/companies/bhaumik-diversified-llc/d7f19efd-9efb-4943-b80d-74b6c3e10f9c

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9