# FDA 483 - SM Biomed Sdn Bhd - March 07, 2013

Source: https://www.keypedia.com/records/483/sm-biomed-sdn-bhd/09c47da4-8513-4d43-ac6e-733f49e050ca

> FDA 483 for SM Biomed Sdn Bhd on March 07, 2013. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SM Biomed Sdn Bhd
- Inspection Date: 2013-03-07
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of SM Biomed Sdn. Bhd. in Sungai Petani, Malaysia, identified significant deficiencies in the cleanliness and maintenance of restrooms within the production facility. The restrooms were observed to be unsanitary, featuring stagnant water, an unwelcome odor, and lacking essential amenities such as self-locking doors, hot water, and proper drying facilities. These conditions indicate a failure in maintaining adequate sanitation and hygiene standards within the manufacturing environment.

## Related Documents

- [483 - 2018-03-23](https://www.keypedia.com/records/483/sm-biomed-sdn-bhd/e8e62394-9a21-453b-b51c-94b675170951)

## Related Officers

- [Branch Chief, Foreign Pharmaceutical Quality Inspection at FDA](https://www.keypedia.com/people/kevin-a-gonzalez/3f0a5230-3804-4df2-9a5e-3ea805ba9b79)

Company: https://www.keypedia.com/companies/sm-biomed-sdn-bhd/0a24751b-1943-43b7-982a-bfa2ec53ff2e

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321