# FDA 483 - TJA Health LLC - January 29, 2024

Source: https://www.keypedia.com/records/483/tja-health-llc/c1738e78-c5a9-4574-b1f6-89a8056a158e

> FDA 483 for TJA Health LLC on January 29, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: TJA Health LLC
- Inspection Date: 2024-01-29
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: An FDA inspection of TJA Health, LLC., an over-the-counter (OTC) drug manufacturer in Joliet, IL, conducted between January 25 and 29, 2024, identified several critical manufacturing and quality control deficiencies. These observations indicate non-compliance with established federal regulations governing drug production. The inspection revealed the absence of written procedures for key production and process controls, notably a lack of process validation for their Plaque-HD OTC Mouth Rinse. The firm also failed to perform required identity testing for raw materials, including active ingredients like Sodium Fluoride, and did not test for hazardous contaminants like Diethylene Glycol and Ethylene Glycol in components such as Glycerin and Sorbitol. Additionally, the company did not adequately investigate instances of microbial contamination in their water system or test for specific objectionable microorganisms, such as Burkholderia cepacia complex, in water used for drug manufacturing. Further issues included a lack of written procedures for annual product reviews, the absence of scientifically established hold times for manufacturing processes, and a failure to implement a robust stability testing program to support product expiration dates for items like Plaque Remineralizing Mouth Rinse. To comply with regulatory standards, TJA Health, LLC. must implement comprehensive corrective actions to ensure the consistent identity, strength, quality, and purity of its drug products.

## Related Documents

- [483 - 2024-01-29](https://www.keypedia.com/records/483/tja-health-llc/64252f43-a445-4090-8d75-34c08f7c8494)

## Related Officers

- [FDA_PERSONNEL](https://www.keypedia.com/people/salvador-dada-chief-operating-officer/4511beb8-2a3b-4606-a843-6a0dc8de180d)
- [Nibin Varghese, Investigator](https://www.keypedia.com/people/nibin-varghese-investigator/3c50e3dd-af60-4934-9b3d-481a178a3ca7)

Company: https://www.keypedia.com/companies/tja-health-llc/ab3662d3-2668-4193-aa92-7b5f27a36ab7

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669