TJA Health, LLC

Warning LetterOpen

Mr. Behnam (Ben) Vaziri Chief Operating Officer TJA Health, LLC 2501 Reeves Road Joliet , IL 60436-9523 United States Bvaziri@plaquehd.comFEI 3010203410Issued Jul 17, 2024Division of Pharmaceutical Quality Operations III

View Letter

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 3010203410.

Violations3

Issue DateJul 17, 2024

Product TypeDrugs

StatusOpen

Letter Details

Firm: TJA Health, LLC
Location: Mr. Behnam (Ben) Vaziri Chief Operating Officer TJA Health, LLC 2501 Reeves Road Joliet , IL 60436-9523 United States Bvaziri@plaquehd.com
FEI Number: 3010203410
Country: United States
Issue Date: July 17, 2024
Issuing Office: Division of Pharmaceutical Quality Operations III
Product Type: Drugs
Status: Open

Summary

TJA Health, LLC's drug manufacturing facility in Joliet, Illinois failed to comply with Current Good Manufacturing Practice (CGMP) regulations, rendering their finished pharmaceutical products adulterated. The company violated 21 CFR 211.84(d)(1) and 211.84(d)(2) by failing to perform required identity and conformity testing on incoming raw materials, including active pharmaceutical ingredients and high-risk components; instead, the firm relied solely on suppliers' certificates of analysis without conducting independent testing. The facility specifically failed to adequately test shipments for contamination risks including diethylene glycol (DEG) and ethylene glycol (EG), creating a significant quality control gap that left the company without scientific evidence that components met specifications before use in drug manufacturing.

TJA Health, LLC FDA Warning Letter, July 17, 2024