# FDA 483 - Teligent Pharma, Inc. - March 08, 2011

Source: https://www.globalkeysolutions.net/records/483/teligent-pharma-inc/77c7b0e4-7e1a-4f33-a08b-2893e810f8c1

> FDA 483 for Teligent Pharma, Inc. on March 08, 2011. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Teligent Pharma, Inc.
- Inspection Date: 2011-03-08
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of IGI Inc., a drug manufacturer in Buena, NJ, revealed significant deficiencies in employee training and experience. The firm's manufacturing compounders were involved in numerous processing deviations due to operator error, and previous corrective actions were found to be ineffective. This indicates a systemic issue with personnel qualifications and quality control in drug product manufacturing.

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## Related Officers

- [Drug Investigator](https://www.globalkeysolutions.net/people/paul-l-bellamy/e94e1ff9-0772-4c1f-af99-a8298983e2f4)

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