# FDA WARNING_LETTER - Colgate Oral Pharmaceuticals, Inc. - August 21, 2014

Source: https://www.keypedia.com/records/warning_letter/colgate-oral-pharmaceuticals-inc/3ff1449e-7be6-41b9-9f27-429779f5337b

> FDA WARNING_LETTER for Colgate Oral Pharmaceuticals, Inc. on August 21, 2014. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Colgate Oral Pharmaceuticals, Inc.
- Inspection Date: 2014-08-21
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Colgate Oral Pharmaceuticals, Inc. for non-compliance with the Generic Drug User Fee Amendments of 2012 (GDUFA). The facility failed to pay the required annual facility fees for fiscal years 2013 and 2014, despite self-identifying as a drug manufacturing facility. This failure constitutes a violation of GDUFA (21 U.S.C. §§ 379j-41 to 379j-42). As a direct consequence, all finished dosage forms of drugs and active pharmaceutical ingredients (APIs) manufactured at the facility are considered misbranded under 21 U.S.C. §§ 352(aa) and 379j-42(g)(4)(A)(iii). Shipping these misbranded products in interstate commerce, including importation into the U.S., is a violation of federal law (21 U.S.C. § 331(a)). The FDA has placed the facility on a publicly available GDUFA facility arrears list. Significant business implications include the non-receipt of any generic drug submissions from Colgate or its affiliates, and new generic drug submissions referencing the facility will also not be received unless outstanding fees are paid within 20 calendar days. The company is required to take prompt action by immediately paying the outstanding 2013 and 2014 fees. Failure to correct these violations may lead to further regulatory actions such as seizure, injunction, or placement on import alert, resulting in refusal of admission for their drugs into the United States. A written response detailing corrective actions is required within 15 working days.

## Related Officers

- [Michael M. Levy](https://www.keypedia.com/people/michael-m-levy/3e0fdd21-e691-406d-81cf-4fe2460a6309)

Company: https://www.keypedia.com/companies/colgate-oral-pharmaceuticals-inc/a9f93a33-c74c-4686-9817-4ddfae84d6e4

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c