Miami University Department of Chemistry and Biochemistry

Warning LetterOpen

Dr. David L. Tierney Principal Investigator Miami University Department of Chemistry and Biochemistry 651 East High Street, Room 160 Oxford , OH 45056 United StatesFEI 3009095423Issued Apr 20, 2022Pharmaceutical Quality Operations Division III

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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 3009095423.

Violations0

Issue DateApr 20, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: Miami University Department of Chemistry and Biochemistry
Location: Dr. David L. Tierney Principal Investigator Miami University Department of Chemistry and Biochemistry 651 East High Street, Room 160 Oxford , OH 45056 United States
FEI Number: 3009095423
Country: United States
Issue Date: April 20, 2022
Issuing Office: Pharmaceutical Quality Operations Division III
Product Type: Drugs
Status: Open

Summary

Miami University's Department of Chemistry and Biochemistry, operating as a contract testing laboratory for pharmaceutical ingredients including heparin, failed to maintain adequate controls over computerized systems to prevent unauthorized data access, changes, or omission of records. The facility's testing operations—which included elemental impurity and identity testing—did not conform to current good manufacturing practice (CGMP) standards, resulting in adulterated active pharmaceutical ingredients. The FDA inspection from November 1-5, 2021, identified significant deviations in data integrity controls that rendered the laboratory's API products non-compliant with federal manufacturing requirements.

Miami University Department of Chemistry and Biochemistry FDA Warning Letter, April 20, 2022