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# 14 Months After FDA Visit, Warning Letter Shocks Pharmacy
- URL: https://www.fdaweb.com/14-months-after-fda-visit-warning-letter-shocks-pharmacy/
- Published: 2016-02-25T12:00:00.000Z
- Updated: 2026-09-15T02:38:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134888

> It hit like a bolt out of the blue. Delivered 2/4 with all the urgency of UPS Next Day Air, the [five-page FDA Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm486700.htm?ref=fdaweb.com) told Myerlee Pharmacy owners **Jeffrey Steele** and **Milton Larrea** they had 15 working days to notify Florida District Office “of the specific steps that you have taken to correct” alleged violations observed during an inspection nearly 14 months before. Those specific steps had, Larrea told ***FDA Webview*** 2/24, been taken already, both in the presence of Florida District investigator **Michael H. Tollon** and in a prompt 1/7/2015 four-page written response to Tollon’s [10-observation FDA-483](http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm430705.pdf?ref=fdaweb.com).  
>  
> Hard to remember for the nine-employee [Fort Myers retail pharmacy’s staff](http://www.myerleepharmacy.com/?ref=fdaweb.com) after all this time, the inspection had focused on their small-scale sterile drug product (human chorionic gonadotropin, super MICCC, testosterone cypionate) compounding business and, according to the Warning Letter, dispensing of [FDA-disapproved domperidone](http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm368736.htm?ref=fdaweb.com) in compounded capsules. No reason for the long-ago inspection had been given, Larrea says, and Tollon’s “belligerence” had reduced one of his employees to tears. His pharmacy is inspected annually by the Florida Pharmacy Board and is licensed for sterile compounding.  
>  
> Over the signature of District director **Susan Turcovski,** FDA’s surprise Warning Letter charged that Tollon had “observed that your firm does not receive valid prescriptions for individually-identified patients” and therefore these compounded drug products “are misbranded drugs in violation of section 502(f)(1) of the FDCA. Furthermore, the domperidone products you produce are also misbranded drugs in violation of section 502(f)(1) of the FDCA.”  
>  
> Larrea, however, says that despite the letter’s use of the present tense to charge ongoing violations 14 months later, the practice of compounding without prescriptions for individually-identified patients was stopped as soon as Tollon mentioned it during the 12/2014 inspection; these products were compounded for physicians for in-office administration to patients who were not identified in the physicians’ orders. The compounding of domperidone capsules pursuant to individual patient-identified written prescriptions, Larrea told ***FDA Webview***, ended shortly thereafter, again on Tollon’s say-so. Neither of these issues was identified in Tollon’s FDA-483, so they were not mentioned in Myerlee Pharmacy’s [written response](http://www.fdaweb.com/download.php?file=Myerlee%5FPharmacy%5F483%5Fresponse.doc).  
>  
> The Warning Letter acknowledged receipt of the pharmacy’s written response but contended that it was “inadequate as the corrective actions do not adequately address the observed insanitary conditions at your facility. Specifically, your response did not indicate an estimated timeframe for the implementation of your proposed corrective actions or include appropriate interim actions to address deficiencies. …”  
>  
> In [response to the Warning Letter](http://www.fdaweb.com/download.php?file=FDA%5FResponse%5F2%5F15%5F16.pdf), Larrea requested a meeting with FDA but settled for what he said was a “very amicable” 29-minute telephone conversation with Florida District compliance officer **Carla A. Norris** in which she indicated the matter would be concluded in a reinspection yet to be scheduled. In his response, Larrea said samples of his sterile drugs also provided to Tollon had been confirmed to be sterile by two separate third-party laboratories, and he asked whether Torcovski's office has “procedures for the development and authorization of Warning Letters? If FDA has such procedures, please provide these and documents which confirm your compliance.”  
>  
> By our deadline, FDA’s Office of Media Affairs had failed to provide a requested explanation for the 14-month delay in issuing both the Myerlee Warning Letter and a similar one issued to an Orlando, FL outsourcing facility, [OPS International](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm486673.htm?ref=fdaweb.com), which comes under a more stringent requirement for GMP compliance as a high-volume compounder.