# FDA 483 - PLIVA Hrvatska d.o.o. - Unknown Date

Source: https://www.keypedia.com/records/483/pliva-hrvatska-doo/6a5fae3e-c82d-4d71-bd0a-435e2b49feca

> FDA 483 for PLIVA Hrvatska d.o.o. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PLIVA Hrvatska d.o.o.
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of Pliva Croatia Ltd. c/o Teva Pharmaceuticals, USA in Horsham, PA, from May 29-31, 2018, identified two observations. The inspection focused on the firm's analytical facility and particle size distribution data. The observations primarily concerned the lack of demonstrated stability for a test product during dialysis and prior to DLS analysis, as well as insufficient documentation of storage conditions.

## Related Officers

- [investigator](https://www.keypedia.com/people/stephanie-c-mangigian/0cf25e6b-1e5d-4088-a13c-11483e2380ba)
- [issuing_officer](https://www.keypedia.com/people/himanshu-gupta/e7b67273-e37d-47b6-b6bb-ca3758116f5d)

Company: https://www.keypedia.com/companies/pliva-hrvatska-doo/b2a312cb-989d-40dc-86f6-25d61db731ad

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4