Has Houston Rx LLC had other FDA inspection citations?

This is the only FDA action Argus HQ has on file for Houston Rx LLC so far. Argus ingests new FDA records daily.

What is the FEI / inspection ID for this Form 483?

FEI / inspection ID: 3045022201.

Is a Form 483 the same as a Warning Letter?

No. A Form 483 lists an FDA investigator’s observations at the close of an inspection; it is not a final agency determination. FDA may or may not follow up with a Warning Letter depending on the firm’s response and the severity of the findings.

Where can I read the full Form 483?

The verbatim inspection record is the source of truth — always confirm citation language against the original FDA document before acting.

Form 483 Record: Houston Rx LLC, August 28, 2026

Key facts

Firm	Houston Rx LLC
FEI / inspection ID	3045022201
Inspection end date	August 28, 2026
Citation count	14

Key takeaway: FDA inspected Houston Rx LLC in Texas and issued a Form 483 listing 14 inspectional observations following an inspection that concluded 2026-08-28. FDA records classify Houston Rx LLC as a producer of sterile drug products. A Form 483 documents an investigator's findings at the close of an inspection under the Federal Food, Drug, and Cosmetic Act; it is not a final agency compliance determination. The observations on this page are drawn directly from the FDA-issued Form 483 record. A Form FDA 483 is issued at the close of an FDA facility inspection to list conditions an investigator observed that may violate the Federal Food, Drug, and Cosmetic Act or its implementing regulations. It reflects the investigator's professional judgment at that point in time and is not a final agency determination, an enforcement action, or proof that a violation occurred. Firms are expected to respond in writing, typically within 15 business days, describing the corrective and preventive actions they plan to take. FDA reviews that response, along with any follow-up evidence, before deciding what happens next. Many 483s are resolved through corrective action alone. When FDA judges a firm's response inadequate, or when the underlying conditions are serious enough, the observations documented here can lead to a Warning Letter or further regulatory action. This page presents the observations exactly as recorded on the FDA-issued document; always confirm citation language against the original record before relying on it.

What a Form 483 means

A Form FDA 483 is issued at the close of an FDA facility inspection to list conditions an investigator observed that may violate the Federal Food, Drug, and Cosmetic Act or its implementing regulations. It reflects the investigator's professional judgment at that point in time and is not a final agency determination, an enforcement action, or proof that a violation occurred. Firms are expected to respond in writing, typically within 15 business days, describing the corrective and preventive actions they plan to take. FDA reviews that response, along with any follow-up evidence, before deciding what happens next. Many 483s are resolved through corrective action alone. When FDA judges a firm's response inadequate, or when the underlying conditions are serious enough, the observations documented here can lead to a Warning Letter or further regulatory action. This page presents the observations exactly as recorded on the FDA-issued document; always confirm citation language against the original record before relying on it.

Citations explained

Observation 1 — Personnel performed aseptic manipulations with exposed hair or skin. Specifically, on

Personnel performed aseptic manipulations with exposed hair or skin. Specifically, on August 24, 2026, while filling/stoppering lot #SMN-082426-5/2-5 of Semaglutide/Niacinamide 5mg /2mg/1ml , we observed one of the operators working in the ISO 5 laminar flow hood with exposed skin on her forehead. The operator was observed entering the ISO 5 LFH, leaning over the bag of sterilized stoppers within the ISO 5 LFH, and placing stoppers on the recently filled vials.

Observation 2 — A pattern of frequent or acute pressure reversals was observed from areas of less clean

A pattern of frequent or acute pressure reversals was observed from areas of less clean air to areas of higher air cleanliness. Specifically, from July 10, 2026 to August 21 , 2026, your system for measuring pressure differential in the cleanrooms indicates negative pressure between the ISO 7 Buffer Room where the ISO 5 Laminar Flow Hoods are located and the ISO 8 Ante Room. The specification is (6) (4) w.c. and every data point documented in this time period was below 0.00" w.c. Your firm has made at least '(b)(•r lots of various drug products in this time period. All have been released. EMPLOYEE(S) SIGNATURE ~-- DATE ISSUED SEE REVERSE Margaret M Annes, cso 8/28/2026 OF THIS PAGE Megan T Ziegler, I nves ti ga t or ~ .~_,,.., X ~Jif"'t oe.28-2026 FORM FDA 483 (09/08) PAGE l of8 PAGES PREVIOUS EDmON OBSOLim! INSPECTIONAL OBSERVATIONS -- 1 of 9 -- DEPART!\fi: NT OF HEALTH Al~ HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS ANO PHONE NUMBER DATE(S) OF I NSPECTI ON 1 20 1 Main S treet, Sui te 7200 8/20/2026 - 8/28/2026* Dallas, TX 75202 FEI NUMBER 30 45 02220 1 (21 4 )253 - 5200 Fax : (21 4 )253 - 5314 NAME ANO TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED St u art E . T olma

Observation 3 — Inadequate =5-.----,,-.- 4.------- testing on (o) ~ ) used to sterilize drug products.

Inadequate =5-.----,,-.- 4.------- testing on (o) ~ ) used to sterilize drug products. --~------ Specifically, your firm is not conducting (6) (-4) testing (15) (-4) ) appropriately as recommended by the(6) (4) manufacturer. Your firm has not identified an appropriate (15) (4) agent and you do not o 4 the (6) (4) before testing. 6 4 , you attach 6 4 - to one end of the (o) (4fa nd attach the other end of the 4 (b) < > to a o 4 . You then 6 4 th e(6) (4) in (o) (4) o 4 from the 6 4 through the ( 6J (4 1 and look for o 4 ..,__.______•. On August 24, 2026, we watched 6 4 testing of the <0><4 > used in the preparation of lot #SMN-082426-5/2-5 of Semaglutide/Niacinamide 5mg /2mg/1ml performed in this manner.

Observation 4 — Personnel were observed manually contacting the inner surface of a sterile container or

Personnel were observed manually contacting the inner surface of a sterile container or closure and manually touching a sterile product contact surface. Specifically, on August 24, 2026, we watched the filling and stoppering of lot #SMN-082426- 5/2-5 of Semaglutide/Niacinamide 5mg /2mg/ 1ml. Your practice is to place the sterile stoppers onto the filled vials using (6) 4 and then pressing down on the stoppers with your o 4 - to push the stopper into the vial.

Observation 5 — Microbial contamination was present in the ISO 5 area. EMPLOYEE(S) SIGNATURE DATE ISSUED

Microbial contamination was present in the ISO 5 area. EMPLOYEE(S) SIGNATURE DATE ISSUED SEE REVERSE Margare t M Annes, cso 8/28/2026 OF THIS PAGE Megan T Ziegler, I nves t iga t o r FORM FDA 483 (09/08) PAGE 2 of8 PAGES PREVIOUS EDmON OBSOLim! INSPE CTIONAL OBSERVATIONS -- 2 of 9 -- DEPART!\fi:NT OF HEALTH Al~ HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS ANO PHONE NUMB ER DATE(S) OF I NSPECTI ON 1 20 1 Main St ree t , Su i t e 7200 8/20/2026 - 8/28/2026* Dallas, TX 75202 FEI NUMB ER 30 4 502220 1 (2 1 4 )253 - 5200 Fax : (2 1 4 )253 - 53 1 4 NAME ANO TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED St u ar t E. T olman, R. Ph . , Pharmacis t- in - Charge FIRM NAME STREET ADDRESS Hou s t on Rx LLC 1 53 4 0 Van t age Pkwy E St e 220 CITY. STATE. ZIP CODE. COUNTRY TYPE ESTABUSHMENT INSPEC TED Hou s t on, TX 77032 - 1 90 1 Prod u cer of St erile Drugs On August 3, 2026, your firm recovered 1CFU in the ISO 5 Laminar Flow Hoo cfll4l (viable surface sample) after the filling/stoppering of lot #TZN-080326-20/2-2 of Tirzepatide/Niacinamide 20/2 mg/ml (2ml vial). No investigation was performed as your firm's action level for ISO 5 areas is 1 (b)<~ CFU, which is not appropriate. The

Observation 6 — The facility is designed and/or operated in a way that permits poor flow of personnel or

The facility is designed and/or operated in a way that permits poor flow of personnel or materials. Specifically, technicians enter the ISO 8 cleanroom area via a door from the unclassified OC bJ (4) )area. Gowning occurs in the ISO 8 area, including washing of hands, on the "clean" side of the demarcation line. There is no designated room or area for gowning. Employees who are gowned and not gowned can interact in the same space while gowning. After formulation, those employees will then enter the ISO 7 cleanroom and work in the ISO 5 hood preparing sterile drug products without changing their garb except for their sterile gloves.

Observation 7 — Sterile drugs were exposed to lower than ISO 5 quality air. Specifically, on August 24,

Sterile drugs were exposed to lower than ISO 5 quality air. Specifically, on August 24, 2026, we watched the filling and stoppering of lot #SMN-082426- 5/2-5 of Semaglutide/Niacinamide 5mg/2mg/1ml. Your practice is to place the sterile stoppers onto the filled vials using !(b) (4) I and then pressing down on the stoppers with your [(b) (4 - to push the stopper into the vial. You then [(b) (4) I of the vials with [(b) (4) - [(b) (4~ the ~ and take them out of the cleanroom. They may be stored overnight in the !(b) (4) r. [(b) (4) I of the vials, which is the final step to finish the closing of the vials, occurs in the unclassified area of the [(o) (-4) . EMPLOYEE(S) SIGNATURE ~- DATE ISSUED SEE REVERSE Margare t M Annes, cso 8/28/2026 OF THIS PAGE Megan T Ziegler, I nves t iga t or ~ .~_,,. - ._ X ~Jir.i: oe.2&-2026 FORM FDA 483 (09/08) INSPECTIONAL OBSERVATIONS PAGE 3 of8 PAGES PREVIOUS EDmON OB SOLim! -- 3 of 9 -- DEPART!\fi:NT OF HEALTH Al~ H UMAN SERV ICES FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS ANO PHONE NUMB ER DATE(S) OF I NSPECTI ON 1 20 1 Main S treet, Sui te 7200 8/20/2026 - 8/28/2026* Dallas, TX 75202 FEI NUMB ER 30 45 022201 (21 4 )253 - 5200 Fax : (21 4 )253 - 531

Observation 8 — Failure to conduct media fills that closely simulate aseptic production operations under

Failure to conduct media fills that closely simulate aseptic production operations under the worst-case, most-challenging, and stressful conditions. Specifically, typical batch sizes for Semaglutide/Niacinamide and Tirzepatide/Niacinamide drug products are 4 '(b> < Y vials. Vial sizes can range from 1ml to 5ml for GLP1 products and up to 10ml for other drug products. Production includes ~b) (4) the drug product into a sterile E <4J filling vials from the KbH<lI of [(6) (4) )drug product using a (6) (4) j , and then manually placing stoppers on the vials. During a media fill , per your Quality Assurance/Compliance Pharmacy Technician, your firm fills [(6) (4 )J- vials. Your firm takes prepared media from a vial, draws it into a (or (4) ] , and then fills the vials using th e'.(6} (4} 1. Your firm also does not document the number of vials filled, incubated and read in the paperwork for the media fills.

Houston Rx LLC’s FDA history

Argus HQ has recorded 1 total FDA action tied to Houston Rx LLC: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.

Frequently asked questions

Has Houston Rx LLC had other FDA inspection citations?: This is the only FDA action Argus HQ has on file for Houston Rx LLC so far. Argus ingests new FDA records daily.
What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 3045022201.
Is a Form 483 the same as a Warning Letter?: No. A Form 483 lists an FDA investigator’s observations at the close of an inspection; it is not a final agency determination. FDA may or may not follow up with a Warning Letter depending on the firm’s response and the severity of the findings.
Where can I read the full Form 483?: The verbatim inspection record is the source of truth — always confirm citation language against the original FDA document before acting.

See if this 483 escalates to a warning letter — before your auditor asks.

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Full FDA history for Houston Rx LLC

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Form 483 Record: Houston Rx LLC, August 28, 2026 — 14 Citations. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/483/houston-rx-3045022201-2026-08-28

MLA

"Form 483 Record: Houston Rx LLC, August 28, 2026 — 14 Citations." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/483/houston-rx-3045022201-2026-08-28.

Chicago

Argus HQ Research. "Form 483 Record: Houston Rx LLC, August 28, 2026 — 14 Citations." Digital Empire Holdings LLC. Accessed October 12, 2026. https://argushq.ai/483/houston-rx-3045022201-2026-08-28.

BibTeX

@misc{argushq_argushq_ai_483_houston_rx_3045022201_2026_08_28_2026,
  title = {Form 483 Record: Houston Rx LLC, August 28, 2026 — 14 Citations},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/483/houston-rx-3045022201-2026-08-28},
  note = {Accessed: October 12, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗