# Teligent Pharma, Inc. – FDA 483, Oct 18, 2017

Source: https://www.keypedia.com/records/483/teligent-pharma-inc/5b9908ee-10b6-4dce-86d5-8e7827cefa10

> FDA 483 for Teligent Pharma, Inc. on October 18, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Teligent Pharma, Inc.
- Inspection Date: 2017-10-18
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Teligent, Inc. in Buena, NJ, was inspected and cited for multiple significant deficiencies in its manufacturing and laboratory controls. Observations included failures to prevent material contamination, inadequate investigations into product failures, unestablished microbiology test method suitability, and insufficient drug product testing and release procedures. Additionally, the firm failed to follow its own laboratory control SOPs and established scientifically sound specifications for drug products.

## Related Documents

- [483 - 2021-08-31](https://www.keypedia.com/records/483/teligent-pharma-inc/c3fc8cd8-7eea-4990-a55a-83119ebd4cdc) — date: August 31, 2021
- [483 - 2019-05-20](https://www.keypedia.com/records/483/teligent-pharma-inc/c9a36aa1-badb-42eb-afed-802e03b6b4e6) — date: May 20, 2019
- [WARNING_LETTER - 2019-05-20](https://www.keypedia.com/records/warning_letter/teligent-pharma-inc/825dc7ec-a2d0-4242-ae51-5ef8e5862271) — date: May 20, 2019
- [EIR - 2017-10-19](https://www.keypedia.com/records/eir/teligent-pharma-inc/3c0b2d21-08a2-4947-bea5-32b577ce04cd) — date: October 19, 2017
- [EIR - 2016-01-22](https://www.keypedia.com/records/eir/teligent-pharma-inc/c4a57990-55b4-4e67-b811-68c4d679b932) — date: January 22, 2016

## Related Officers

- [Investigator](https://www.keypedia.com/people/nancy-m-espinal/f4494790-6a37-4998-853c-f859a0eb3330)

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

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248