Houston Rx LLC
Form 483 issued August 28, 2026 · Houston, Texas
- Inspection
- Aug 20 – Aug 28, 2026
- Investigators
- Margaret M. Annes· Megan Ziegler
- Observations
- 14
- Pages
- 9
- FEI number
- 3045022201
In short: On August 28, 2026, FDA issued a Form 483 with 14 observations to Houston Rx LLC in Houston, Texas (FEI 3045022201) after an inspection that ran Aug 20 – Aug 28, 2026. The investigators were Margaret M. Annes and Megan Ziegler. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 11 of 14 observations.
Most cited: 21 CFR 211.113 (6×) · 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Personnel performed aseptic manipulations with…
- 02
A pattern of frequent or acute pressure reversals was observed from areas of less clean air…
- 03
Inadequate =5-.----,,-.- 4. - - - - - - - testing on (o) ~ ) used…
- 04
Personnel were observed manually contacting the inner surface of a sterile container or closure and manually…
This inspection in context
Margaret M. Annes
60 documents · 2007–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmHouston Rx LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Houston Rx LLC?
FDA listed 14 observations on this Form 483, mostly about production, facilities & equipment and materials. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Houston Rx LLC?
Margaret M. Annes and Megan Ziegler are named on this Form 483, for the inspection of Aug 20 – Aug 28, 2026. Each investigator has a profile showing what they cite most.
When was Houston Rx LLC inspected by FDA?
The inspection ran Aug 20 – Aug 28, 2026, and the Form 483 is dated August 28, 2026.
How do I get the full Form 483 for Houston Rx LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.