# FDA EIR - Klocke of America, Inc. - April 27, 2016

Source: https://www.keypedia.com/records/eir/klocke-of-america-inc/bc275726-2d86-4f27-8e72-b5bf8beb9e2f

> FDA EIR for Klocke of America, Inc. on April 27, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Klocke of America, Inc.
- Inspection Date: 2016-04-27
- Product Type: drugs
- Office Name: Office of Pharmaceutical Quality Operations Division III
- Summary: An abbreviated FDA inspection of Klocke of America in Fort Myers, FL, was conducted on April 27, 2016. This inspection, classified as a FY 2016 Tier 1 drug inspection, focused on the company's operations as a repacker of topical pain relief and sun protection over-the-counter (OTC) drug products. The review was performed under compliance programs 7356.002 for Drug Manufacturing Inspections and 7356.002B for Drug Repackagers and Relabelers. The inspection encompassed the quality, packaging, and labeling systems for unit dose OTC drug creams and lotions. Reviewed records included organizational charts, labels, training files, standard operating procedures, batch records, certificates of analysis, and distribution documentation. Significantly, the inspection concluded with no observations requiring a Form FDA 483, indicating no significant violations or issues were identified. No samples were collected, and no warnings were issued. While no immediate corrective actions were mandated, the report recommended that the firm's stability testing program be thoroughly reviewed during the subsequent inspection to ensure ongoing adherence to quality standards and proper product dating. The company demonstrated an operational training program, and its complaint review process showed no issues related to OTC drug products.

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## Related Officers

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

Office: https://www.keypedia.com/offices/office-of-pharmaceutical-quality-operations-division-iii/d84ec753-c6a8-4319-aacf-918334923f13