# FDA 483 - Transdermal Therapeutics Inc. - June 27, 2014

Source: https://www.keypedia.com/records/483/transdermal-therapeutics-inc/1b5c45a7-4c46-4a99-a49e-898f71415bbc

> FDA 483 for Transdermal Therapeutics Inc. on June 27, 2014. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Transdermal Therapeutics Inc.
- Inspection Date: 2014-06-27
- Product Type: Drugs
- Office Name: New Orleans District Office
- Summary: The FDA Form 483 details multiple deficiencies observed during an inspection. The facility fails to conduct appropriate laboratory testing for identity and strength of each active ingredient in drug products prior to release, specifically lacking potency testing for each active ingredient per lot/batch.

There are no written procedures for production and process controls, and the manufacturing process has not been validated to assure identity, strength, quality, and purity. The facility accepts supplier reports of analysis for components without performing at least one specific identity test or validating supplier analyses, and does not conduct additional raw material testing or verify Certificates of Analysis.

Complaint handling procedures are deficient, lacking provisions for quality control review of specification failures, investigation of unexplained discrepancies, and determination of reasons for batch failures. Investigations do not extend to other batches or associated components, and procedures do not address reporting serious and unexpected adverse drug experiences to FDA.

Written procedures for equipment cleaning and maintenance are absent, and cleaning validation has not been performed. There is no written stability testing program, and no scientific data supports assigned beyond-use dates or shelf-life, including for products produced in advance. Reserve drug product samples are not retained under consistent labeling conditions. Finally, calibration of recording devices is not done at suitable intervals; specifically, calibration weights for scales used in component weighing are not certified.

## Related Documents

- [145 - 2017-03-02](https://www.keypedia.com/records/145/transdermal-therapeutics-inc/9953b897-8567-4787-99a9-172473fb9e30)

## Related Officers

- [CO CDER OMQ](https://www.keypedia.com/people/claire-minden/f48982ad-244e-41a8-932a-5d7a2392f0e3)

Company: https://www.keypedia.com/companies/transdermal-therapeutics-inc/642ddcdc-b223-4b0c-bcac-462a8009f3e2

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