# FDA WARNING_LETTER - Chinese Peptide Company - May 15, 2012

Source: https://www.globalkeysolutions.net/records/warning_letter/chinese-peptide-company/8866b076-691b-4d23-9122-82ce222c254e

> FDA WARNING_LETTER for Chinese Peptide Company on May 15, 2012. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Chinese Peptide Company
- Inspection Date: 2012-05-15
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Chinese Peptide Company on February 28, 2012, due to failure to fulfill drug establishment registration obligations. The company, located at Number 69, 12th Street, Economic and Technological Development Zone, Hangzhou, China, FEI: 3004518843, continued to manufacture and import drugs into the U.S. in 2011 and 2012 without annual registration, despite being notified by the FDA on October 11, 2011.

This violates Section 510(i)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 360(i)(1)), which requires annual electronic registration for foreign establishments manufacturing drugs imported into the U.S. Failure to register is a prohibited act under Section 301(p) (21 U.S.C. § 331(p)). Additionally, drugs cannot be imported unless listed per 21 CFR Part 207, Subpart C, and manufactured at a registered foreign establishment (21 CFR § 207.40(b)). Unregistered drugs may be refused admission under Section 801(o) or 801(a)(3) if appearing adulterated or misbranded. Failure to list drugs as required by Section 51

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## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/chinese-peptide-company/ba8c6a32-f679-405b-bb0a-e82713b7cb62

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