# FDA 483 - PT. TEAM-METAL INDONESIA - August 08, 2018

Source: https://www.keypedia.com/records/483/pt-team-metal-indonesia/41d2f541-08a1-4dc6-9700-f9bbe21074b7

> FDA 483 for PT. TEAM-METAL INDONESIA on August 08, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PT. TEAM-METAL INDONESIA
- Inspection Date: 2018-08-08
- Product Type: device
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of PT. TEAM-METAL INDONESIA, a medical device manufacturer in Batam, Indonesia, revealed a significant issue with process validation. The firm failed to adequately validate machining processes for critical medical device components, relying on sampling rather than full verification. This indicates a serious lapse in quality system procedures related to ensuring product quality and safety.

## Related Documents

- [483 - 2018-08-06](https://www.keypedia.com/records/483/pt-team-metal-indonesia/74f59a04-a558-4be4-a9ab-9ac9a8ae6647)

## Related Officers

- [James R. Montero](https://www.keypedia.com/people/james-r-montero/ce2d19fd-25b7-423e-9132-5d6f582380d2)

Company: https://www.keypedia.com/companies/pt-team-metal-indonesia/4896e88c-8dc1-47bb-a8ec-d4a18490c01c

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