# FDA 483 - Caltag Medsystems Ltd - May 04, 2023

Source: https://www.globalkeysolutions.net/records/483/caltag-medsystems-ltd/6ee22e0b-01c6-4b91-8640-25e8b70820e4

> FDA 483 for Caltag Medsystems Ltd on May 04, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Caltag Medsystems Ltd
- Inspection Date: 2023-05-04
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Caltag Medsystems Ltd, a medical device manufacturer in Buckingham, United Kingdom, revealed significant deficiencies in their quality system. Observations included inadequate design review, lack of established design transfer procedures, insufficient process validation, and poorly documented corrective and preventive actions. These issues indicate a need for improved adherence to quality system regulations.

## Related Documents

- [WARNING_LETTER - 2023-05-04](https://www.globalkeysolutions.net/records/warning_letter/caltag-medsystems-ltd/00da0ec1-2c5c-4224-91d3-313810f9810b)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/sarah-a-hassas/4f142d54-fc28-4bd5-82ad-7e6fa443688c)

Company: https://www.globalkeysolutions.net/companies/caltag-medsystems-ltd/a758291c-4847-45d3-b616-fb03cbb8bb63

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