# FDA WARNING_LETTER - Meds4U - September 06, 2019

Source: https://www.keypedia.com/records/warning_letter/meds4u/cea0de87-1bb1-460b-a770-4058e95c40a1

> FDA WARNING_LETTER for Meds4U on September 06, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Meds4U
- Inspection Date: 2019-09-06
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA and DEA issued a joint Warning Letter to Meds4U on September 6, 2019, addressing the unlawful online sale of opioids and other drugs to U.S. consumers, citing the severe public health crisis of opioid addiction. The DEA determined that Meds4U operates as an "online pharmacy" without the required modified DEA registration, unlawfully distributing, dispensing, and advertising controlled substances, including opioids, in violation of the Ryan Haight Online Pharmacy Consumer Protection Act (21 U.S.C. §§ 841(h), 843(c)). Concurrently, the FDA found Meds4U introduces unapproved new drugs, such as unapproved tramadol 200mg tablets, into interstate commerce, violating sections 301(d) and 505(a) of the FD&C Act (21 U.S.C. §§ 331(d), 355(a)). Furthermore, these drugs are misbranded under section 502(f)(1) (21 U.S.C. § 352(f)(1)) due to a lack of adequate directions for use, leading to a violation of section 301(a) (21 U.S.C. § 331(a)). Meds4U is directed to immediately cease all violative sales and notify both agencies within 15 working days of corrective actions. Failure to comply could lead to severe legal actions, including seizure, injunctions, and contacting domain name registrars, with potential civil or criminal proceedings.

## Related Officers

- [Director](https://www.keypedia.com/people/donald-d-ashley/060f0dda-e6e8-4f9c-97e7-f540d523d902)
- [Deputy Assistant Administrator](https://www.keypedia.com/people/neil-doherty/cb2d404a-984a-4ad6-b8a8-647bb234b06e)

Company: https://www.keypedia.com/companies/meds4u/44b998f0-60f8-4e26-8620-07832dd24b6d

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