# FDA 483 - Misemer Pharmaceutical - February 23, 2026

Source: https://www.keypedia.com/records/483/misemer-pharmaceutical/ee8f2b1b-e017-472d-a95c-f6f5f81199fd

> FDA 483 for Misemer Pharmaceutical on February 23, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Misemer Pharmaceutical
- Inspection Date: 2026-02-23
- Product Type: drugs
- Office Name: Kansas City District Office
- Summary: Misemer Pharmaceutical, Inc., an own-label distributor based in Ripley, Mississippi, underwent an FDA inspection from February 17 to February 23, 2026. The inspection identified several critical failures regarding the company"s drug safety reporting obligations. The primary violations involved the consistent failure to submit mandatory safety reports to the FDA within the required timeframes. Specifically, the firm failed to submit ten quarterly adverse drug experience reports for Fenoprofen and repeatedly filed late annual reports for Ketoprofen and Chlordiazepoxide between 2023 and 2025. Additionally, the FDA found that the company lacked comprehensive written procedures for reporting post-marketing adverse drug experiences. While the firm"s existing guidelines assigned responsibility for reporting, they did not describe the actual steps or processes required to complete these filings. These failures represent a breach of the regulatory framework established under the Federal Food, Drug, and Cosmetic Act, which mandates strict reporting schedules to monitor drug safety after products reach the market. To address these findings, Misemer Pharmaceutical is expected to respond to the FDA with a detailed corrective action plan. This plan must outline how the company will update its procedures, rectify missing filings, and ensure future compliance with all reporting deadlines to maintain public safety standards.

## Related Documents

- [483 - 2026-02-23](https://www.keypedia.com/records/483/misemer-pharmaceutical/fd010587-cd1b-4ca0-bf4c-570ecc1165e5)

## Related Officers

- [investigator](https://www.keypedia.com/people/kellie-r-riggs/556818c6-eb9a-48a5-9630-aba7a807ec07)

Company: https://www.keypedia.com/companies/misemer-pharmaceutical/8519598e-b9c3-4cfa-a622-37863a4f50fe

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79