# FDA WARNING_LETTER - Health Technology Inc. - May 16, 2012

Source: https://www.keypedia.com/records/warning_letter/health-technology-inc/292263eb-0db7-4edb-af26-75fdbdce9017

> FDA WARNING_LETTER for Health Technology Inc. on May 16, 2012. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Health Technology Inc.
- Inspection Date: 2012-05-16
- Product Type: Food
- Office Name: Atlanta District Office
- Summary: From May 8-16, 2012, the FDA inspected a dietary supplement manufacturing facility in Dawson, Georgia, identifying serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111) and dietary supplement labeling requirements. These violations render the firm's dietary supplements adulterated and misbranded.

Key CGMP violations include:
- Failure to prepare and follow written Master Manufacturing Records (MMRs) for each unique formulation and batch size (21 CFR 111.205(a), 111.210).
- Failure to establish product specifications for identity, purity, strength, composition, and contamination limits of finished batches (21 CFR 111.70(e)).
- Failure to maintain written records for production and process control systems, including procedures for receiving and rejecting components, packaging, and labels, and documentation of raw material examination (21 CFR 111.180(b)(1), 111.180(b)(3)).
- Failure to maintain written records for equipment, specifically calibration procedures and records, and maintenance, cleaning, and sanitizing procedures (21 CFR 111.35(b)(1)(i), 111.35(b)(3), 111.35(b)(1)(iii)).
- Failure to maintain written records for

## Related Officers

- [John R. Gridley](https://www.keypedia.com/people/john-r-gridley/32a64db5-8914-4eb2-93ea-e41da190edd7)

Company: https://www.keypedia.com/companies/health-technology-inc/93ffe156-a481-4f07-8f0f-6d08e0e9348b

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