# FDA 483 - SM Biomed Sdn Bhd - March 23, 2018

Source: https://www.keypedia.com/records/483/sm-biomed-sdn-bhd/e8e62394-9a21-453b-b51c-94b675170951

> FDA 483 for SM Biomed Sdn Bhd on March 23, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SM Biomed Sdn Bhd
- Inspection Date: 2018-03-23
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of SM Biomed Sdn. Bhd. in Sungai Petani, Malaysia, revealed a significant issue regarding the validation of a printer used for imprinting critical information onto API templates. The firm lacked documented evidence that the specific printer in use had been validated, with a discrepancy noted between the validated printer's identification and the printer actually utilized. This indicates a potential control weakness in their labeling process for active pharmaceutical ingredients.

## Related Documents

- [483 - 2013-03-07](https://www.keypedia.com/records/483/sm-biomed-sdn-bhd/09c47da4-8513-4d43-ac6e-733f49e050ca)

## Related Officers

- [Reba Gates](https://www.keypedia.com/people/reba-gates/fa0bc5c9-e94f-4471-a40d-39f15305906b)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd