Teligent Pharma, Inc.

Form 483FOIA Uncovered

Buena, New Jersey, United StatesFEI 1000526875Issued August 31, 2021

View FDA's Record for This Firm

Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 1000526875.

Observations15

Issue DateAugust 31, 2021

Status1 Related Warning Letter

Related Inspections8

Establishment Details

Firm: Teligent Pharma, Inc.
Location: Buena, New Jersey, United States
FEI Number: 1000526875
Product Type: Drugs
Issue Date: August 31, 2021
Country: United States

Inspection History, 2009 to 2021

NAI5

VAI2

OAI1

NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.

Act on This Form 483

FDA Inspection ReadinessSee how your operations would hold up to the same scrutiny.CAPA & InvestigationsScore how you would investigate and close findings like these.Talk to a SpecialistWalk through these observations with a ComplianceQuest expert.

Teligent Pharma, Inc. FDA Form 483, Buena, New Jersey, August 31, 2021