# FDA 483 - Hi-Tech Pharmaceuticals Inc. - March 24, 2023

Source: https://www.keypedia.com/records/483/hi-tech-pharmaceuticals-inc/34853cee-8fda-4df2-bca1-6de636b262ed

> FDA 483 for Hi-Tech Pharmaceuticals Inc. on March 24, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hi-Tech Pharmaceuticals Inc.
- Inspection Date: 2023-03-24
- Product Type: other
- Office Name: Atlanta District Office
- Summary: Hi-Tech Pharmaceuticals Inc. received a Form 483 citing multiple significant deficiencies in its quality control and manufacturing processes for dietary supplements. Key issues include releasing products with non-conforming components and out-of-specification results, inadequate labeling, insufficient identity testing, and a lack of scientifically valid test methods and proper supplier qualification. Many of these observations are repeats from previous inspections, indicating persistent compliance problems.

## Related Documents

- [483 - 2021-03-30](https://www.keypedia.com/records/483/hi-tech-pharmaceuticals-inc/f14f6ba7-433d-4821-a856-60baf52c9714)

## Related Officers

- [investigator](https://www.keypedia.com/people/rashonda-n-rucker/68c5db63-be23-4aaa-89c4-2e692193321e)
- [Consumer Safety](https://www.keypedia.com/people/joseph-f-owens/68cda862-335d-4de4-8abd-bf83a96a76bb)
- [Founder](https://www.keypedia.com/people/crystal-a-harlan/905c0385-615f-4a4b-a362-394605568620)
- [Brenda Rivera](https://www.keypedia.com/people/brenda-rivera/b7f32d1e-c9a2-444c-a14b-968367db3264)

Company: https://www.keypedia.com/companies/hi-tech-pharmaceuticals-inc/f2be5f4c-a707-4de1-9243-b03b9120bdf7

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7