Megan M. Maloney
President/Quality Assurance/Regulatory Affairs
Iso-Tex Diagnostics, Inc.
1511 County Road 129
Alvin , TX 77511
United StatesFEI 1626310Issued Jul 20, 2023Division of Pharmaceutical Quality Operations II
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 1626310.
Violations4
Issue DateJul 20, 2023
Product TypeDrugs
StatusOpen
Letter Details
Firm
Iso-Tex Diagnostics, Inc.
Location
Megan M. Maloney
President/Quality Assurance/Regulatory Affairs
Iso-Tex Diagnostics, Inc.
1511 County Road 129
Alvin , TX 77511
United States
FEI Number
1626310
Country
United States
Issue Date
July 20, 2023
Issuing Office
Division of Pharmaceutical Quality Operations II
Product Type
Drugs
Status
Open
Summary
Iso-Tex Diagnostics, Inc. was cited for Current Good Manufacturing Practice (CGMP) violations in their drug manufacturing facility that rendered their drug products adulterated. FDA inspectors found that the company failed to maintain properly designed cleanrooms with adequate materials for cleaning and disinfection, and failed to establish sufficient environmental monitoring and control systems in aseptic processing areas to prevent contamination of sterile drug products. The facility's deficient design, unsuitable equipment, and inadequate environmental conditions created significant contamination risks for drugs intended to be sterile.
Iso-Tex Diagnostics, Inc. FDA Warning Letter, July 20, 2023
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