MD Pharmaceutical Supply, LLC

Warning LetterOpen

Mr. Richard J. Romeo Owner and President MD Pharmaceutical Supply, LLC P.O. Box 244 Hanover , PA 17331-2921 United StatesFEI 3012369470Issued Nov 22, 2022Division of Pharmaceutical Quality Operations I

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3012369470.

Violations3

Issue DateNov 22, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: MD Pharmaceutical Supply, LLC
Location: Mr. Richard J. Romeo Owner and President MD Pharmaceutical Supply, LLC P.O. Box 244 Hanover , PA 17331-2921 United States
FEI Number: 3012369470
Country: United States
Issue Date: November 22, 2022
Issuing Office: Division of Pharmaceutical Quality Operations I
Product Type: Drugs
Status: Open

Summary

MD Pharmaceutical Supply, LLC, a drug repackaging and relabeling facility, failed to comply with current good manufacturing practices (CGMP) for active pharmaceutical ingredients (APIs), rendering their APIs adulterated. During an April-May 2022 inspection, the FDA identified critical deficiencies including failure to adequately investigate customer complaints and quality issues before redistributing returned API lots, and discrepancies in certificates of analysis (COAs) where the company distributed APIs using COAs with incorrect expiration dates that differed from documentation provided by the original manufacturer. Specifically, the company redistributed a phentolamine mesylate API lot that had been returned for quality issues without proper investigation, and later distributed aminocaproic acid API using a COA with an April 2024 expiration date when the actual COA showed April 2023.

MD Pharmaceutical Supply, LLC FDA Warning Letter, November 22, 2022