# FDA 483 - PROMEPLA - May 16, 2018

Source: https://www.keypedia.com/records/483/promepla/d4059a53-8e42-41c1-b906-60fd3fdcc7ef

> FDA 483 for PROMEPLA on May 16, 2018. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PROMEPLA
- Inspection Date: 2018-05-16
- Product Type: other
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of PROMEPLA in Monaco identified a single observation related to inadequate documentation of corrective and preventive action (CAPA) activities. Specifically, the firm failed to establish sufficient acceptance criteria to verify the effectiveness of corrective actions. This indicates a deficiency in the firm's quality system regarding CAPA procedures.

## Related Officers

- [investigator](https://www.keypedia.com/people/ronald-ifraimov/b4ce8b79-3fa2-4862-b7a4-68e14e45d87a)

Company: https://www.keypedia.com/companies/promepla/e75790ce-8af4-4a01-8612-f6d7f462cfc3

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