# FDA WARNING_LETTER - Midland Pharmaceutical LLC - September 05, 2007

Source: https://www.keypedia.com/records/warning_letter/midland-pharmaceutical-llc/1b066f08-90bf-44db-a92f-9784a6ec845d

> FDA WARNING_LETTER for Midland Pharmaceutical LLC on September 05, 2007. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Midland Pharmaceutical LLC
- Inspection Date: 2007-09-05
- Product Type: Drugs
- Office Name: Kansas City District Office
- Summary: The FDA issued a Warning Letter to Midland Pharmaceutical LLC following a July-September 2007 inspection, citing numerous deviations from Current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211) for finished pharmaceuticals. These violations render their drug products, specifically Sulfamethoxazole/Trimethoprim (SMZ/TMP) USP tablets, adulterated under Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act).

Key violations include:
1.  **Inadequate Production and Process Controls (21 CFR § 211.100(a)):** Deficient process validation for SMZ/TMP tablets, lacking defined ranges for critical steps, scientifically sound retrospective validation, inclusion of lower-strength products, consistent settings, and stability evaluation for changed parameters. The firm also failed to implement a change control program for significant process parameter alterations.
2.  **Failure to Follow Written Procedures (21 CFR § 211.100(b)):** Manufacturing processes were not conducted within established critical parameters, and deviations were not recorded or justified.
3.  **Inadequate Investigations (21 CFR § 211.192):** Out-of-specification (OOS) results for Content Uniformity, drug residue, and appearance were not thoroughly investigated. Corrective actions, such as test method changes

## Related Officers

- [District Director](https://www.keypedia.com/people/john-w-thorsky/7a765cf2-aafc-48f7-98f5-172795a7d0d8)

Company: https://www.keypedia.com/companies/midland-pharmaceutical-llc/65d77afe-a8b4-4930-91d1-1df7eb15e3b3

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