# FDA 483 - Teligent Pharma, Inc. - May 20, 2019

Source: https://www.globalkeysolutions.net/records/483/teligent-pharma-inc/c9a36aa1-badb-42eb-afed-802e03b6b4e6

> FDA 483 for Teligent Pharma, Inc. on May 20, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Teligent Pharma, Inc.
- Inspection Date: 2019-05-20
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Teligent Pharma, Inc. in Buena, NJ, a drug manufacturer, was cited for significant deficiencies across its quality control, production, and quality systems. The inspection revealed failures in rejecting out-of-specification drug products, inadequate investigations into stability failures, widespread issues with laboratory and production records, and non-adherence to stability testing programs and complaint handling procedures. Additionally, the firm failed to submit required NDA Field Alert Reports and complete annual product reviews, indicating systemic control issues.

## Related Documents

- [483 - 2011-03-08](https://www.globalkeysolutions.net/records/483/teligent-pharma-inc/77c7b0e4-7e1a-4f33-a08b-2893e810f8c1)
- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/teligent-pharma-inc/c7ba4387-57bf-4488-8eb6-4612c443258e)
- [483 - 2017-10-18](https://www.globalkeysolutions.net/records/483/teligent-pharma-inc/5b9908ee-10b6-4dce-86d5-8e7827cefa10)
- [WARNING_LETTER - 2019-05-20](https://www.globalkeysolutions.net/records/warning_letter/teligent-pharma-inc/825dc7ec-a2d0-4242-ae51-5ef8e5862271)
- [483 - 2021-08-31](https://www.globalkeysolutions.net/records/483/teligent-pharma-inc/c3fc8cd8-7eea-4990-a55a-83119ebd4cdc)

## Related Officers

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

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

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