# FDA 483 - Klocke of America, Inc. - March 30, 2022

Source: https://www.keypedia.com/records/483/klocke-of-america-inc/506a08b4-3968-4168-b210-874fad93da57

> FDA 483 for Klocke of America, Inc. on March 30, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Klocke of America, Inc.
- Inspection Date: 2022-03-30
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Klocke of America, Inc., an OTC Drug Repacker in Fort Myers, FL, was cited for four observations during an FDA inspection. The findings indicate significant deficiencies in the firm's quality control unit procedures, including lack of written procedures, improper logbook management, and deficient procedure approval processes. Additionally, the facility exhibited structural issues, equipment cleaning validation was inadequate, and computer systems for balance weights lacked validation.

## Related Officers

- [Dorothy P. Kramer](https://www.keypedia.com/people/dorothy-p-kramer/12e3c8b6-6359-43cc-96fd-ba2097225e3d)
- [Investigator ](https://www.keypedia.com/people/nicole-e-knowlton/8e65400f-249f-45fe-96fc-cb00fec6ae39)
- [Damaris Y. Hernandez](https://www.keypedia.com/people/damaris-y-hernandez/ca16093e-047b-4bf1-bcc1-c439cff21e8a)

Company: https://www.keypedia.com/companies/klocke-of-america-inc/5fc107e0-8b4f-47be-9d74-7a9c028a52f2

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6