RPK Pharmaceuticals Inc.

Warning LetterClosed

Rich Mangini RPK Pharmaceuticals Inc. 3281 Whipple Rd Union City , CA 94587 United StatesFEI 2937511Issued Mar 26, 2021Center for Drug Evaluation and Research

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 2937511.

Violations2

Issue DateMar 26, 2021

Product TypeDrugs

StatusClosed

Closeout LetterJun 7, 2021

Letter Details

Firm: RPK Pharmaceuticals Inc.
Location: Rich Mangini RPK Pharmaceuticals Inc. 3281 Whipple Rd Union City , CA 94587 United States
FEI Number: 2937511
Country: United States
Issue Date: March 26, 2021
Issuing Office: Center for Drug Evaluation and Research
Product Type: Drugs
Status: Closed
Closeout Letter: June 07, 2021

Summary

RPK Pharmaceuticals Inc. was cited for failure to comply with drug listing requirements and misbranding of their clotrimazole and betamethasone dipropionate cream product (NDC 53002-9740). The company submitted a label image stating "triamcinolone 0.1% ointment" to FDA's Drug Registration and Listing System, which did not match the actual drug product listed—representing a violation of Section 510(j) of the Federal Food, Drug, and Cosmetic Act. This compliance failure followed two prior FDA notices issued in April and May 2020 regarding the same listing deficiency, which ultimately resulted in the product's removal from FDA's Online NDC Directory.

RPK Pharmaceuticals Inc. FDA Warning Letter, March 26, 2021