# FDA WARNING_LETTER - Noven Pharmaceuticals, Inc. - July 02, 2007

Source: https://www.globalkeysolutions.net/records/warning_letter/noven-pharmaceuticals-inc/13431909-56a4-4a42-95f0-771a92570fd5

> FDA WARNING_LETTER for Noven Pharmaceuticals, Inc. on July 02, 2007. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Noven Pharmaceuticals, Inc.
- Inspection Date: 2007-07-02
- Product Type: Drugs
- Office Name: Florida District Office
- Summary: An FDA inspection of Noven Pharmaceuticals, Inc. from June to July 2007 revealed that their Daytrana® methylphenidate TD patches are adulterated under 21 U.S.C. § 351(a)(2)(B) due to non-conformity with cGMP regulations (21 CFR Part 211).

Key violations include:
1.  **Failure to establish scientifically sound specifications (21 CFR § 211.160(b))**: A liner release force specification for Daytrana® patches was absent, despite historical data showing variability in peel force. The company failed to evaluate this data or justify the lack of a commercial product specification. FDA requested an explanation for not developing an "adequate database" since 2002 and further data evaluation. While Noven provided a new specification in October 2007, FDA requested rationale, data, and clarification on its relevance and incorporation into stability protocols.
2.  **Failure to assure drug product quality throughout expiry (21 CFR § 211.137(a))**: Noven lacked data to assure acceptable release characteristics for the new [redacted] release liner over the 24-month expiry period, despite acknowledging age-related "tight release" and/or "adhesive transfer" issues. FDA questioned the scientific basis for the 24-month expiry given the lack of real-

## Related Documents

- [WARNING_LETTER - 2011-02-14](https://www.globalkeysolutions.net/records/warning_letter/noven-pharmaceuticals-inc/b319ddec-a6b7-44df-95f2-cb9980583d51)

## Related Officers

- [District Director](https://www.globalkeysolutions.net/people/emma-r-singleton/e0b72aba-caa5-4cf8-8beb-6f93f6654e59)
- [Compliance Officer](https://www.globalkeysolutions.net/people/brant-m-schroeder/1da637d9-4db9-47d6-8382-9a38ea64c338)

Company: https://www.globalkeysolutions.net/companies/noven-pharmaceuticals-inc/62bebbb8-11dc-4e9a-8d6d-f347dde4fa0a

Office: https://www.globalkeysolutions.net/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9