# FDA WARNING_LETTER - Sharon Bio-Medicine Limited - Unknown Date

Source: https://www.keypedia.com/records/warning_letter/sharon-bio-medicine-limited/42a56939-d52b-4c6a-b314-5ec3a58ff23c

> FDA WARNING_LETTER for Sharon Bio-Medicine Limited on Unknown Date. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Sharon Bio-Medicine Limited
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Warning Letter, dated June 22, 2015, addresses Sharon Bio-Medicine Limited (FEI - 3005925733) in India for failing to pay required facility fees under the Generic Drug User Fee Amendments of 2012 (GDUFA).

The facility, identified in pending and/or approved generic drug submissions, failed to pay annual facility fees for fiscal years 2013, 2014, and 2015, despite self-identifying for these years. This non-payment renders all finished dosage forms of drugs or active pharmaceutical ingredients (APIs), and drugs containing APIs manufactured at the facility, as misbranded under 21 U.S.C. §§ 352(aa) and 379j-42(g)(4)(A)(iii).

Regulatory citations highlight that shipping misbranded products in interstate commerce, including importation into the U.S., is a violation of federal law (21 U.S.C. § 331(a)). Consequences include potential injunctions, seizures (21 U.S.C. §§ 332, 334), and denial of entry into the U.S. (21 U.S.C. § 381(a)(3)).

The facility has been placed on a publicly available GDUFA facility arrears

## Related Officers

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

Company: https://www.keypedia.com/companies/sharon-bio-medicine-limited/d68573b5-5697-415c-b3a9-30e805a8620b

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