# FDA WARNING_LETTER - Health Science Products Inc - August 10, 2011

Source: https://www.keypedia.com/records/warning_letter/health-science-products-inc/efe840a9-1dcb-4588-8a7e-96ff1aee9be6

> FDA WARNING_LETTER for Health Science Products Inc on August 10, 2011. Product: Devices. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Health Science Products Inc
- Inspection Date: 2011-08-10
- Product Type: Devices
- Office Name: New Orleans District Office
- Summary: During a July-August 2011 inspection, the FDA found Health Science Products, Incorporated, a manufacturer of dental chairs and operative units, in violation of the Federal Food, Drug, and Cosmetic Act. The devices are adulterated under 21 USC § 351(h) because manufacturing, packing, storage, or installation methods do not conform to Quality System (QS) regulation (21 CFR Part 820).

Violations include:
- Failure to establish and maintain CAPA procedures (21 CFR 820.100(a)).
- Failure to establish and maintain purchasing control procedures (21 CFR 820.50).
- Failure to establish and maintain complaint procedures (21 CFR 820.198(a)).
- Failure to establish and maintain process control procedures (21 CFR 820.70(a)).
- Failure to adequately document acceptance activities (21 CFR 820.80(e)).
- Failure to maintain adequate Device Master Records (DMRs) (21 CFR 820.181).
- Failure to maintain adequate Device History Records (DHRs) (21 CFR 820.184).
- Failure to establish and maintain document control procedures (21 CFR 820.40).

Additionally, devices are misbranded under 21

## Related Documents

- [WARNING_LETTER - 2014-01-23](https://www.keypedia.com/records/warning_letter/health-science-products-inc/c8013d7a-2874-44c3-9808-695d087014c2)
- [483 - 2019-08-23](https://www.keypedia.com/records/483/health-science-products-inc/3f4cb951-73bd-4fee-9b8b-571589710e26)

## Related Officers

- [Patricia K. Schafer](https://www.keypedia.com/people/patricia-k-schafer/34b879a1-8a40-40f0-a526-e56ac62665e9)
- [Compliance Officer](https://www.keypedia.com/people/kari-l-batey/d7c20e11-04eb-4b3a-879f-8d34472322c4)

Company: https://www.keypedia.com/companies/health-science-products-inc/980eb62e-99cd-4b3a-b504-8470f9d92359

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea