# FDA 483 - Wickliffe Pharmaceutical Inc - May 22, 2014

Source: https://www.keypedia.com/records/483/wickliffe-pharmaceutical-inc/dc5e4f53-ae59-4796-a3bf-5052bac8a61b

> FDA 483 for Wickliffe Pharmaceutical Inc on May 22, 2014. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wickliffe Pharmaceutical Inc
- Inspection Date: 2014-05-22
- Product Type: Drugs
- Office Name: Cincinnati District Office
- Summary: This FDA Form 483 document details inspectional observations made at Wickliffe Pharmaceutical Inc., a compounding pharmacy located at 4340 Georgetown Rd., Lexington, KY 40511. The inspection was conducted on April 29-30, 2014, and May 9, 14, 22, 2014, by Kathleen Dant Culver, Investigator/Drug Preapproval Manager. The report is issued to Jacqueline S. Bernard, President and Owner.

Two key observations relate to the potency of compounded drug products:

1.  **Lot 28-03-2014@44 (BUD 9/24/2014) of toltrazuril and pyrimethamine suspension**, labeled to contain 416 mg/ml toltrazuril and 17 mg/ml pyrimethamine, and dispensed under Rx #294545, showed significant deviations:
    *   Pyrimethamine was found at 405 +/- 69 mg/ml, which is 2380% of the declared potency.
    *   Toltrazuril was found at 15.5 +/- 2.5 mg/ml, which is 3.74% of the declared potency.

2.  **Lot 25-03-20

## Related Documents

- [WARNING_LETTER - 2014-05-22](https://www.keypedia.com/records/warning_letter/wickliffe-pharmaceutical-inc/439aaf79-d2ed-4c03-82ce-7e051dfa025b)
- [483 - 2016-04-07](https://www.keypedia.com/records/483/wickliffe-pharmaceutical-inc/92fe152b-9097-480a-8a59-7ed2f6d5d578)
- [AMENDED_483 - 2023-09-15](https://www.keypedia.com/records/amended_483/wickliffe-pharmaceutical-inc/5098ba4c-fe5d-4f58-a5b7-8579515da56f)
- [483_RESPONSE - 2023-09-15](https://www.keypedia.com/records/483_response/wickliffe-pharmaceutical-inc/6e52a9b3-9a08-4849-8d99-5bbb8024469c)
- [UNTITLED_LETTER - 2023-09-07](https://www.keypedia.com/records/untitled_letter/wickliffe-pharmaceutical-inc/2a133e07-0650-4846-9910-fe6b849886c9)

## Related Officers

- [Investigator](https://www.keypedia.com/people/kathleen-dant-culver/fe43f228-7c7a-47ea-94cb-349324553012)

Company: https://www.keypedia.com/companies/wickliffe-pharmaceutical-inc/86fc3eb8-322a-47f6-8828-f8ccfe8a1f53

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22