# FDA 483 - Sachem Europe BV - February 06, 2020

Source: https://www.keypedia.com/records/483/sachem-europe-bv/f45db336-09ab-4eda-bf81-a797b7778a7b

> FDA 483 for Sachem Europe BV on February 06, 2020. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Sachem Europe BV
- Inspection Date: 2020-02-06
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Sachem Europe BV, an API Intermediate Manufacturer in Zaltbommel, Gelderland, Netherlands, was inspected by the FDA from February 3-6, 2020. The inspection resulted in one observation concerning the firm's failure to fully follow written laboratory control procedures. Specifically, deviations were noted in HPLC analysis run times without proper documentation.

## Related Officers

- [Andrew J. Barrowcliff](https://www.keypedia.com/people/andrew-j-barrowcliff/5dd49407-9028-4c84-9e86-3f0b6239538e)

Company: https://www.keypedia.com/companies/sachem-europe-bv/65ad9152-dcb7-4fbd-965e-324c36970c85

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1