1Aseptic processing and sterility assurance
Sterile drugs were exposed to lower than ISO 5 quality air.
Inspection Record
Houston Rx LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Use of ingredients not intended for pharmaceutical use in sterile drug production.
3Aseptic processing and sterility assurance
Sterile products were exposed to non-sterile or non-depyrogenated supplies.
4Other quality system
Inadequate <Redacted B4> testin g on <Redacted B4> used to sterilize drug products.
5Stability and storage
Your firm is not storing active pharmaceutical ingredients (API) per the labeled storage conditions.
6Other quality system
A pattern of frequent or acute pressure reversals was observed from areas of less clean air to areas of higher air cleanliness.
7Aseptic processing and sterility assurance
Failure to conduct media fills that closely simulate aseptic production operations under the worst-case, most-challenging, and stressful conditions.
8Equipment and facility
The facility is designed and/or operated in a way that permits poor flow of personnel or materials.
9Aseptic processing and sterility assurance
Personnel were observed manually contacting the inner surface of a sterile container or closure and manually touching a sterile product contact surface.
10Aseptic processing and sterility assurance
Personnel performed aseptic manipulations with exposed hair or skin.
11Contamination control
Microbial contamination was present in the ISO 5 area.
12Contamination control
Contamination was observed in your areas adjacent to production areas.
13Cleaning validation
Use of cleaning and disinfecting agents that may leave residues or not adequately rinsing such agents from containers, closures, or equipment that come into direct contact with drug products.
14Aseptic processing and sterility assurance
Biological indicators were not used to verify the adequacy of the sterilization cycle.
About this record
Extracted automatically from the document US FDA published on 2026-10-01. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
