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FDA establishment 3021758709, Houston, Texas, United States. Part of Empower Clinic Services LLC's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
Inspections: 3
Official action indicated: 3
Last inspection ended: Nov 14, 2025
Warning letters: 2
Recalls since 2016: 2
Inspections by Fiscal Year
FY2018 to FY2027 to date; 3 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
FDCA 501(a)(2)(A). Personnel moving quickly, disrupting unidirectional airflow Personnel were observed moving quickly in a critical area or in an area immediately adjacent to a critical area likely causing disruption of unidirectional airflow.
FDCA 501(a)(2)(A). Personnel, blocked or disrupted first air Personnel were observed conducting aseptic manipulations where the movement of "first air" in the ISO 5 area is blocked or disrupted.
FDCA 501(a)(2)(A). Failure to clean and disinfect/sterilize equipment, ISO 5 area Failure to appropriately and regularly clean and disinfect or sterilize equipment located in the ISO 5 area.
FDCA 501(a)(2)(A). Microbial contamination was present, ISO 5/areas adjacent Microbial contamination was present in the ISO 5 area.
FDCA 501(a)(2)(A). Media fills, failure Failure to conduct media fills that closely simulate aseptic production operations under the worst-case, most-challenging, and stressful conditions.
FDCA 501(a)(2)(A). Inadequate smoke studies Smoke studies were inadequately performed under dynamic conditions.
Official Action Indicated (OAI)
Oct 4, 2024
Drugs · Drug Quality Assurance
8 cited references
FDCA 501(a)(2)(A). Use of non-pharmaceutical, ingredients/processing aides Use of ingredients not intended for pharmaceutical use in non-sterile drug production.
FDCA 501(a)(2)(A). Media fills, failure Failure to conduct media fills that closely simulate aseptic production operations under the worst-case, most-challenging, and stressful conditions.
FDCA 501(a)(2)(A). Production areas, difficult to clean/particle generating Production areas have difficult to clean or contain porous, particle generating, or visibly dirty equipment or surfaces.
FDCA 501(a)(2)(A). Beta-lactam, hazardous, highly potent drugs, prevention of cross-contamination Hazardous drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination.
FDCA 501(a)(2)(A). Lack of/inadequate, environmental monitoring Inadequate routine environmental monitoring in the ISO 5 area.
FDCA 501(a)(2)(A). Lack of, routine certification of the ISO 5 Lack of routine certification of the ISO 5 area.
FDCA 501(a)(2)(A). Failure to clean and disinfect/sterilize equipment, ISO 5 area Failure to appropriately and regularly clean and disinfect or sterilize equipment located in the ISO 5 area.
FDCA 501(a)(2)(A). Inadequate smoke studies Smoke studies were not and were inadequately performed under dynamic conditions.
Official Action Indicated (OAI)
Dec 1, 2023
Drugs · Drug Quality Assurance
8 cited references
FDCA 501(a)(2)(A). Biological indicators, not used Biological indicators were not used to verify the adequacy of the sterilization cycle.
FDCA 501(a)(2)(A). Use of non-pharmaceutical, ingredients/processing aides Use of ingredients not intended for pharmaceutical use in sterile drug production.
FDCA 501(a)(2)(A). Lack of/inadequate, environmental monitoring Inadequate routine environmental monitoring in the ISO 5 area and classified areas.
FDCA 501(a)(2)(A). Personnel infrequently, changed/sanitized gloves Personnel infrequently changed and sanitized gloves to prevent contamination.
FDCA 501(a)(2)(A). Failure/inadequate, filter integrity testing Inadequate post-use filter-integrity testing on filters used to sterilize drug products.
FDCA 501(a)(2)(A). Failure to clean and disinfect/sterilize equipment, ISO 5 area Failure to appropriately and regularly clean and disinfect or sterilize equipment located in the ISO 5 area.
FDCA 501(a)(2)(A). Personnel, blocked or disrupted first air Personnel were observed conducting aseptic manipulations where the movement of "first air" in the ISO 5 area is blocked or disrupted.
FDCA 501(a)(2)(A). Components/containers/materials, endotoxin contamination Compounding with components, containers or other materials that have not been verified to assure that they do not contribute endotoxin contamination that may be objectionable given the product's intended use.
Official Action Indicated (OAI)
Warning Letters
Letters naming this establishment; each opens the letter
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard, warning letters and enforcement reports
Houston, Texas, United States. Part of