# FDA WARNING_LETTER - Larken Laboratories - December 31, 2009

Source: https://www.keypedia.com/records/warning_letter/larken-laboratories/5f30710e-de5f-4c67-b896-78e51849f792

> FDA WARNING_LETTER for Larken Laboratories on December 31, 2009. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Larken Laboratories
- Inspection Date: 2009-12-31
- Product Type: Drugs
- Office Name: New Orleans District Office
- Summary: This FDA Warning Letter, NO. 2010-NOL-03, was issued to Scott Allen, President of Larken Laboratories, on an unspecified date in 2010. It references a prior warning letter issued on (b)(4) 2009 to (b)(4), a manufacturer with whom Larken Laboratories contracted.

The letter states that Larken Laboratories distributes drug products manufactured by (b)(4), including "(b)(4) (each (b)(4) contains: (b)(4))", "(b)(4) Suspension Drops (each (b)(4) contains: (b)(4))", and "(b)(4) Suspension Drops (each (b)(4) contains: (b)(4))".

These products are classified as "new drugs" under Section 201(p) of the Act [21 USC 321(p)] because they are not generally recognized as safe and effective. The FDA asserts that there are no approved applications (NDA/ANDA) on file for these drug products, violating Sections 301(d) and 505(a) of the Act [21 USC 331(a), (d) and 355(a)].

Furthermore, the prescription drug products are deemed misbranded under Section 502(f)(1) of the Act [21 USC 352(

## Related Officers

- [H.](https://www.keypedia.com/people/tyler-thornburg/611c288f-255c-4a1a-9914-14ff1363e7b3)

Company: https://www.keypedia.com/companies/larken-laboratories/059febd3-344b-4ab0-bbbf-1cb98056b03f

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea