# FDA 483 - Teligent Pharma, Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/teligent-pharma-inc/c7ba4387-57bf-4488-8eb6-4612c443258e

> FDA 483 for Teligent Pharma, Inc. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Teligent Pharma, Inc.
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Teligent, Inc. in Buena, NJ, revealed significant deficiencies in their in-vitro bioequivalence studies. The firm failed to properly retain reserve samples, maintain adequate drug accountability records, and ensure the scientific validity of their analytical methods. These issues indicate a lack of control over critical aspects of their BE study conduct and data integrity.

## Related Documents

- [483 - 2011-03-08](https://www.keypedia.com/records/483/teligent-pharma-inc/77c7b0e4-7e1a-4f33-a08b-2893e810f8c1)
- [483 - 2017-10-18](https://www.keypedia.com/records/483/teligent-pharma-inc/5b9908ee-10b6-4dce-86d5-8e7827cefa10)
- [483 - 2019-05-20](https://www.keypedia.com/records/483/teligent-pharma-inc/c9a36aa1-badb-42eb-afed-802e03b6b4e6)
- [WARNING_LETTER - 2019-05-20](https://www.keypedia.com/records/warning_letter/teligent-pharma-inc/825dc7ec-a2d0-4242-ae51-5ef8e5862271)
- [483 - 2021-08-31](https://www.keypedia.com/records/483/teligent-pharma-inc/c3fc8cd8-7eea-4990-a55a-83119ebd4cdc)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/himanshu-gupta/e7b67273-e37d-47b6-b6bb-ca3758116f5d)

Company: https://www.keypedia.com/companies/teligent-pharma-inc/1605ff29-0e1f-49ed-9bba-a5f897375249

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