Warning letter to a pharmacy · Office of Pharmaceutical Quality
FDA warning letter 663403 to Curexa – East, LLC dba Curexa
Issued September 13, 2023 to a compounding pharmacy, not to a seller. 4 seller records name Curexa as a pharmacy that fills orders, so the letter is disclosed on those records beside S3, pharmacy identification. It changes no disposition.
The letter, as filed
| Number | MARCS-CMS 663403 |
|---|---|
| Issued | September 13, 2023 |
| Addressee | Curexa – East, LLC dba Curexa |
| Address | 3007 Ocean Heights Avenue, Egg Harbor Township, NJ 08234-7749 |
| Recipient | Mark K. Taylor, CEO and Pharmacist-in-Charge |
| Issuing office | Office of Pharmaceutical Quality |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Establishment | FDA Establishment Identifier 3011761882 |
| Sections cited | 501(a)(2)(A), 301(a), 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 August 29, 2022, to September 9, 2022, U.S. Food and Drug Administration (FDA) investigators inspected your facility, Curexa – East, LLC dba Curexa, located at 3007 Ocean Heights Avenue, Egg Harbor Township, NJ 08234.
“During the inspection, the investigators noted serious deficiencies in your practices for producing drug products, which put patients at risk.”
“The FDA investigators noted that drug products were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA.”
“Non-microbial contamination was observed in the production area.”
“Your firm produced hazardous drugs without providing adequate cleaning of utensils, components, or containers to prevent cross-contamination.”
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 is addressed to a company doing business as Curexa, at 3007 Ocean Heights Avenue, Egg Harbor Township, New Jersey, which is the address curexa.com prints for Curexa Pharmacy, and its contact address is on the curexa.com domain. 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:
- Alloy: Curexa Pharmacy in Egg Harbor Township, New Jersey, with a street address of 10 Canale drive, which is not the address in the letter.
- Hers: EHT Pharmacy doing business as Curexa.
- Hims: EHT Pharmacy doing business as Curexa.
- Wisp: Curexa.
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 663403 to Curexa – East, LLC dba Curexa, 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.