Ryan Goodkin, Co-Owner
Jack P. Herick, Inc., dba Glades Drugs
109 S. Lake Avenue
Pahokee, FL 33476-1803
Dear Mr. Goodkin:
From November 23, 2015, to December 10, 2015, a U.S. Food and Drug Administration (FDA) investigator conducted an inspection of your facility, Jack P. Herick, Inc. (dba Glades Drugs), located at 109 S. Lake Avenue, Pahokee, FL 33476-1803. This inspection was conducted after receipt of three adverse event reports associated with vitamin D3 supplement capsules prepared by your firm.
FDA issued a Form FDA 483 to your firm on December 10, 2015. FDA acknowledges receipt of your firm’s response to the Form FDA 483, dated December 16, 2015.
Based on this inspection, it appears that you are producing drugs that violate the Federal Food, Drug, and Cosmetic Act (FDCA).
A. Violations of the FDCA
Adulterated Drug Products
As noted, FDA received three MedWatch reports, dated November 12, 13, and 17, 2015, regarding adverse events experienced by three patients who were hospitalized after ingesting vitamin D3 supplement capsules produced by your firm. FDA collected samples of your products labeled as containing 25 grams of cholecalciferol per capsule. FDA analysis of these samples found that they contained a range of approximately 435,600 to 39,000,000 IU/gram of cholecalciferol per capsule, which far exceeds the label claim. Under section 501(c) of the FDCA [21 U.S.C. § 351(c)], a drug is adulterated if it is unrecognized in an official compendium and its strength differs from, or its quality or purity falls below, that which it purports or is represented to possess. The strength of your cholecalciferol product differed from and greatly exceeded the labeled amount of cholecalciferol the product was purported to possess, causing it to be adulterated under section 501(c) of the FDCA.
It is a prohibited act under section 301(k) of the FDCA to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce of the components used to make the drug and results in the drug being adulterated.
Misbranded Drug Products
Under section 502(a) of the FDCA [21 U.S.C. § 352(a)], a drug product is misbranded if its labeling is false or misleading in any particular. As noted, FDA analysis showed that your vitamin D3 capsule contained in excess of the labeled concentration of cholecalciferol. Because the labeling of this drug product was false, it was misbranded under section 502(a) of the FDCA.
It is a prohibited act under section 301(k) of the FDCA to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce of the components used to make the drug and results in the drug being misbranded.
B. Corrective Actions
We acknowledge your action on November 25, 2015, to voluntarily recall compounded multivitamin capsules containing high amounts of vitamin D3 (cholecalciferol), distributed nationwide by your firm, and subsequently issued recall letters to patients indicating that vitamin D was the superpotent MVI ingredient, listing the signs and symptoms of Vitamin D toxicity, and advising patients to seek medical attention immediately.
FDA strongly recommends that your management immediately undertake a comprehensive assessment of your operations, including facility design, procedures, personnel, processes, materials, and systems.
The violations cited in this letter are not intended to be an all-inclusive statement of violations at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you do not believe that the products discussed above are in violation of the FDCA, include your reasoning and any supporting information for our consideration. Your written notification should be addressed to:
Andrea Norwood, Compliance Officer
FDA Florida District Office
U.S. Food and Drug Administration
555 Winderley Place Suite 200
Maitland, FL 32751
If you need additional information please contact the FDA. You may respond in writing to Andrea Norwood, Compliance Officer. If you have any questions about the contents of this letter, please contact Dr. Andrea Norwood at 407-475-4724 (phone) or 407-475-4768(fax).
Susan M. Turcovski
Director, Florida District