# FDA EIR - Tishcon Corp - November 20, 2017

Source: https://www.keypedia.com/records/eir/tishcon-corp/82a8500f-32f3-4896-9d5f-e3f7bb7cf43e

> FDA EIR for Tishcon Corp on November 20, 2017. Product: Dietary Supplements. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Tishcon Corp
- Inspection Date: 2017-11-20
- Product Type: Dietary Supplements
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Tishcon Corp., a dietary supplement manufacturer and distributor located in Westbury, NY, was conducted from November 13-20, 2017. This was the firm's initial inspection under 21 CFR 111, the regulatory framework for dietary supplement Good Manufacturing Practices. The inspection revealed several significant violations documented on Form FDA 483. These included the failure to adequately verify that finished batches of dietary supplements met product specifications for identity, purity, strength, and composition, as evidenced by insufficient testing for active ingredients in products such as Children's Vita-Gels Softgels. Additionally, quality control personnel released a raw material with an out-of-specification assay test result for EPA without proper documentation or investigation. The firm also lacked adequate documentation to justify how their in-process and component specifications ensured finished product quality, particularly concerning the absence of upper limit specifications for active ingredients, which resulted in substantial overages that could lead to misbranding. Furthermore, the company was inappropriately using National Drug Code (NDC) numbers on their dietary supplement labels. Tishcon Corp. management stated they would submit a written response to the FDA Form 483 observations within 15 business days and committed to discontinuing the use of NDC numbers on their product labeling.

## Related Documents

- [483 - 2017-11-20](https://www.keypedia.com/records/483/tishcon-corp/7c5e20c7-a0b4-4b62-9647-8cd8dc68c354)
- [EIR - 2022-04-12](https://www.keypedia.com/records/eir/tishcon-corp/8b189d48-af8f-4ffe-ae7f-0f11c01398ca)

## Related Officers

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Company: https://www.keypedia.com/companies/tishcon-corp/a780a8ca-0e6b-41fb-b487-d2729bb0f88f

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961