Warning letter to a pharmacy · Center for Drug Evaluation and Research (CDER)
FDA warning letter 694687 to Right Value Drug Stores, LLC dba Carie Boyd Pharmaceuticals
Issued December 17, 2024 to a compounding pharmacy, not to a seller. 1 seller record names Carie Boyd Pharmaceuticals as a pharmacy that fills orders, so the letter is disclosed on that record beside S3, pharmacy identification. It changes no disposition.
The letter, as filed
| Number | MARCS-CMS 694687 |
|---|---|
| Issued | December 17, 2024 |
| Addressee | Right Value Drug Stores, LLC dba Carie Boyd Pharmaceuticals |
| Address | 2501 W. Oak Street, Denton, TX 76201 |
| Recipient | Evan Gilbert, CEO |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Sections cited | 501(a)(2)(A), 501(a)(2)(B), 502(f)(1), 505(a), 301(a), 301(d), 301(k) of the Federal Food, Drug, and Cosmetic Act |
| Close-out letter | None on the index when this letter was added. |
What it says
The letter rests on an inspection: From May 28, 2024, to June 21, 2024, an FDA investigator inspected your facility, Right Value Drug Stores, LLC dba Carie Boyd Pharmaceuticals, located at 8400 Esters Blvd, Suite 190, Irving, TX 75063.
“During the inspection, the investigator noted that drug products you produced failed to meet the conditions of section 503B of the FDCA necessary for drugs produced by an outsourcing facility to qualify for exemptions from certain provisions of the FDCA.”
“In addition, the investigator noted serious deficiencies in your practices for producing drug products, which put patients at risk.”
“Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area.”
“Your media fills were not performed under the most challenging or stressful conditions.”
Quoted exactly as the letter prints them. The letter describes the facility on the dates of that inspection; it says nothing about any seller, and this site adds nothing to it.
How it was attributed
The letter cites the facility of a company doing business as Carie Boyd Pharmaceuticals at 8400 Esters Blvd, Suite 190, Irving, Texas, which is the address Carie Boyd's own website prints for its Irving 503B pharmacy and the address the record prints. The letter is mailed to the company's Denton, Texas office. The letter is tied to the pharmacy entry in this ledger's pharmacy registry, never to a seller: no seller is named in it.
Records that name this pharmacy
Each record below names the pharmacy under S3, in the seller's own words:
- DoctorAdam: Carie Boyd Pharmaceuticals, with a street address of 8400 Esters Blvd Ste 190, which is not the address in the letter.
What it changes on a record
Nothing in any disposition. S8, enforcement status, asks about the seller's own operating entity, and a letter to a pharmacy it names is not one. The Standard asks a seller to name its pharmacy so that a reader can look the facility up; this page is that lookup, and each record above links here from its S3 row.
Sources
- FDA warning letter 694687 to Right Value Drug Stores, LLC dba Carie Boyd Pharmaceuticals, read in full
- FDA, About Warning and Close-Out Letters
- FDA warning letter index, and its close-out column
The letter is quoted from its own page on fda.gov, as it stood on the date in the meta line above. This page ranks nothing, recommends nothing, and carries no partner link.