Mr. Richard A. Gilbert
President
Missouri Analytical Laboratories Inc
1820 Delmar Boulevard
Saint Louis , MO 63103
United StatesFEI 1946524Issued Sep 30, 2021Division of Pharmaceutical Quality Operations III
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 1946524.
Violations2
Issue DateSep 30, 2021
Product TypeDrugs
StatusClosed
Closeout LetterOct 15, 2024
Letter Details
Firm
Missouri Analytical Laboratories Inc
Location
Mr. Richard A. Gilbert
President
Missouri Analytical Laboratories Inc
1820 Delmar Boulevard
Saint Louis , MO 63103
United States
FEI Number
1946524
Country
United States
Issue Date
September 30, 2021
Issuing Office
Division of Pharmaceutical Quality Operations III
Product Type
Drugs
Status
Closed
Closeout Letter
October 15, 2024
Summary
Missouri Analytical Laboratories Inc, a contract testing laboratory, received a warning letter for significant Current Good Manufacturing Practice (CGMP) violations related to drugs and active pharmaceutical ingredients. During an inspection in May 2021, the FDA found that the firm failed to thoroughly investigate unexplained discrepancies and out-of-specification test results, instead relying on resampling and retesting to invalidate original failures without establishing root causes or providing adequate scientific justification. The firm's inadequate investigation procedures and lack of proper controls rendered their drugs adulterated under federal law.
Missouri Analytical Laboratories Inc FDA Warning Letter, September 30, 2021
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