# FDA WARNING_LETTER - C.P.M. Contract Pharma GmbH & Co. KG - January 14, 2014

Source: https://www.keypedia.com/records/warning_letter/cpm-contract-pharma-gmbh-co-kg/eebe9c54-1262-414c-bbce-e272340d2b52

> FDA WARNING_LETTER for C.P.M. Contract Pharma GmbH & Co. KG on January 14, 2014. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: C.P.M. Contract Pharma GmbH & Co. KG
- Inspection Date: 2014-01-14
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Warning Letter, GDUFA-13-001, dated September 17, 2013, was issued to C.P.M. Contract Pharma GmbH & Co. KG for failing to self-identify their facility and pay the required facility fees under the Generic Drug User Fee Amendments of 2012 (GDUFA).

The facility, identified as a finished dosage form manufacturer, failed to self-identify for fiscal years 2013 (due by December 3, 2012) and 2014 (due between May 1 and June 1, 2013), and did not pay the fiscal year 2013 facility fees (due March 4, 2013). These failures violate 21 U.S.C. §§ 379j-41-379j-42.

As a result, all drugs or active pharmaceutical ingredients manufactured at the facility are considered misbranded under 21 U.S.C. §§ 352(aa) and 379j-42(g)(4)(iii). Shipping misbranded products into U.S. interstate commerce is a violation of federal law (21 U.S.C. § 331(a)), potentially leading to injunctions, seizures (21 U.S.C. §§ 33

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## Related Officers

- [Douglas Stearn](https://www.keypedia.com/people/douglas-stearn/63f9e646-7970-4dc1-a731-869bbe2cf4be)

Company: https://www.keypedia.com/companies/cpm-contract-pharma-gmbh-co-kg/603d56c1-f951-4a2d-9098-cd2fc6ee54f6

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