FDA Inspection
Houston Rx LLCHouston Rx LLC – FDA Inspection, Aug 28, 2026
Record Details
This FDA Inspection record concerns Houston Rx LLC, with an inspection on August 28, 2026, issued by the Dallas District Office, covering human drugs.
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ID · d24abc3c-acd4-4ee1-9517-673eb99513d0
Inspection Facts
- Inspection number
- 1324528
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
13- FDCA 501(a)(2)(A)Biological indicators, not used
- FDCA 501(a)(2)(A)Cleaning/disinfecting agents, residues/inadequate rinsing
- FDCA 501(a)(2)(A)Contamination, production area/adjacent areas
- FDCA 501(a)(2)(A)Exposed to lower quality air/ISO 5
- FDCA 501(a)(2)(A)Failure/inadequate, filter integrity testing
- FDCA 501(a)(2)(A)Flow of personnel and materials, facility
- FDCA 501(a)(2)(A)Media fills, failure
- FDCA 501(a)(2)(A)Microbial contamination was present, ISO 5/areas adjacent
- FDCA 501(a)(2)(A)Personnel exposure during aseptic manipulations
- FDCA 501(a)(2)(A)Personnel, using non-sterile tool, manually contacting/touching sterile product
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