What is an FDA Form 483?

A Form FDA 483 lists an FDA investigator’s written observations at the close of a facility inspection, issued under section 704(b) of the Federal Food, Drug, and Cosmetic Act. It documents conditions the investigator judged may violate FDA regulations. A 483 is not an enforcement action or a final determination that a violation occurred.

What happens after a Form 483 is issued?

The firm typically has 15 business days to submit a written response describing planned corrections. FDA reviews that response, and unresolved or serious findings can lead to a Warning Letter, import alert, or other enforcement action, though many 483s are resolved without further FDA action.

June 4, 2026 FDA Form 483 for Lt Col Luke Weather Jr Veterans Affairs Medical Center

Q: Does this Form 483 mean Lt Col Luke Weather Jr Veterans Affairs Medical Center violated the law?

No. A Form 483 documents an investigator's observations only. FDA reviews the firm's written response and any corrective actions taken before deciding whether further action is warranted, and many 483s are closed without additional enforcement once a firm shows adequate correction.

Q: Has Lt Col Luke Weather Jr Veterans Affairs Medical Center had other FDA inspection citations?

This is the only FDA action Argus HQ has on file for Lt Col Luke Weather Jr Veterans Affairs Medical Center so far. Argus ingests new FDA records daily.

Key facts

Firm	Lt Col Luke Weather Jr Veterans Affairs Medical Center
FEI / inspection ID	1074265
Inspection end date	June 4, 2026
Citation count	6

In short: FDA inspected Lt Col Luke Weather Jr Veterans Affairs Medical Center in Tennessee and issued a Form 483 listing 6 inspectional observations following an inspection that concluded 2026-06-04. FDA records classify Lt Col Luke Weather Jr Veterans Affairs Medical Center 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.

Citations explained

Observation 1 — Personnel were observed conducting aseptic manipulations where the movement of "first

Personnel were observed conducting aseptic manipulations where the movement of "first air" in the ISO 5 area is blocked or disrnpted. Specifically, On 5/27/2026, the operator was observed conducting aseptic manipulations in which the movement of first air in the ISO 5 LAF it:j was block ed dming the aseptic production of the fo llowing sterile drng products: • Sodium Phosphate 15mmol in Dextrose 5% l 00mL, Order ID: naph os052726, BUD 06/06/2026 • Cefepime 2g, Order ID: cefep ime2052726, BUD: 06/ 11 /2026 The operator's hand placement was observed blocking the bag po1i and needle, and vial stopper and needle. The operator 's hands were positioned in a manner that obstructed the unidirectional "first air" between the HEPA filter and the critical work smface. On 5/28/2026, the operator was obs erved conducting aseptic manipulations in which the movement of first air in the ISO 5 LAFH fbX 4 jwas blocked dming the aseptic production of the following sterile drng products: • Daptomycin (Cubicin) 75 0 mg/NS 50 mL , Order ID: 84305997, BUD: 05/30/2026 EMPLOYEE(S) SI GNATURE DATE ISSUED SEE REVERSE Demari o L Wa lls , I n ve s t i ga t o r 6/ 4 /2026 OF THIS PAGE oen.loLWl h ~ CIQWOOL w,,u

Observation 3 — Personnel were obse1ved moving quickly in a critical area or in an area immediately

Personnel were obse1ved moving quickly in a critical area or in an area immediately adjacent to a critical area likely causing disrnption of unidirectional airflow. Specifically, On 06/02/2026, during aseptic production operations, an operator was obse1ved moving quickly within ISO 5 LAFH JtJ while per fo1ming aseptic manipulations. At the time of the obse1v ation, the operator had an exposed, filled syringe of s te rile drng product in han d. Rapid personnel movement within the ISO 5 critic al zone is likely to disrnpt unidirectional ( fi rst air) airflow, thereby compromising the sterile air baiTi er protecting exposed diu g products and critical sites from potential inicrobial and paii iculate contamination. The following diug products were being aseptically produced at the time of this obse1vation: • Daptomycin 75 0 mg in Sodium Chloride 0.9% 50 mL, BUD 06/04/2026, Order ID: 84305998 • Sodium Bicarbonate 8 .4% 150 mEq in Dext ro se 5% 1000 mL, BUD: 06/03/2026, Order ID: 84327268

Observation 4 — La ck of disinfection of supplies at each transition from ai·eas of lower quality air to

La ck of disinfection of supplies at each transition from ai·eas of lower quality air to ai·e as of higher quality air. EMPLOYEE(S) SI GNATURE DATE ISSUED SEE REVERSE De mari o L Wa lls , I n ve s t i g a t o r 6/ 4 /2026 OF THIS PAGE oen.loL Wl h ~ CIQWOOL w,,u_a . x ~rO&<lt-2ll26 F ORM FDA ~83 ( 09/08) PAGE 3 of!O PAGES PREVIOUS EDmON OBSOLEJE INS PEC TIONAL OB SERVATIONS -- 3 of 11 -- DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION D I STRI CT ADDRESS ANO PH ONE NUMBER OATE(S) OF I NSPEC TION 404 BNA Dr . , Bldg . 200, St e . 500 5/27/2026 - 6/4/2026* Na shville, TN 37217 - 2597 FEJNUMBER 10 74265(61 5)366 - 7801 Fax : (61 5)366 - 7802 NAME AND T ITLE OF I NDIVIDUAL TO WHOM R EPORT ISSUED Edward Pay t on, Exec ut ive Direc t or F IRM NAME STREET ADDRESS Lt Col Luke Wea t her Jr Ve t erans Affairs 116 N Pa ul ine St Medical Cent er ( 113) C ITY . STATE. ZIP CODE. COUITTRY TYPE ESTABUSI-NE NT INSPECTED Memphis, TN 38104 - 2193 Prod uc er of St erile Drug Prod uc t s Specifically, On 5/28/2026, during the aseptic production of the fo llowing diug products: • Daptomycin (Cubicin) 75 0 mg/NS 50 mL, Order ID: 84305997, BUD: 05/30/2026 • Cefepime/Sodium Chloride 0.

Observation 5 — Smoke studies were inadequately perfo1med under dynainic conditions. Specifically, your

Smoke studies were inadequately perfo1med under dynainic conditions. Specifically, your fom failed to adequately per fo1m smoke studies under dynainic conditions to demonstrate unidirectional airflow, simulate aseptic production, simulate worst-case conditions EMPLOYEE(S) SI GNATURE DATE ISSUED SEE REVERSE Demario L Walls, I nves t iga t or 6/4/2026 OF THIS PAGE oen.loL Wl h ~CIQWOO L w,,u_a . x ~rO&<lt-2ll26 PAGE4of!0 PAGES FORM FDA ~83 (09/ 08) PREVIOUS EDmON OBSOLEJE INS PEC TIONAL OB SERVATIONS -- 4 of 11 -- DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION D I STRI CT ADDRESS ANO P HONE NUMBER OATE(S) OF INSPEC TION 404 BNA Dr., Bl dg . 200 , S te. 500 5/27/2026 - 6/ 4 /2026* Na shville , TN 372 17- 2597 FEJNUMBER 107 4265(61 5)366 - 7801 Fax: (61 5)366 - 7802 NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED Edward Payt on , Exe cu tive Di re c t o r F IRM NAME STREET ADDRESS Lt Col Luke Weat he r Jr Veterans Affairs 11 6 N Pau line St Medical Center ( 11 3) C ITY . STATE. ZIP CODE. COUITTRY TYPE ESTABUSI-NE NT INSPECTED Memphis, TN 38104- 2193 Pr oduce r of S teri le Dru g Pr oduc t s including all components, materials, and equipment present during actua

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-challeng ing, and s b.'essful conditions. Specifically, your fnm 's m edia fill protocol does n ot closely simulate the manipulations, container/closure configu rations, or fill volumes used during actual production operations. For example, • During actual productionr(fi:operators u se syringe(s) to adinix diug product into prefill ed bags, sometimes changing the 6) (4) ~ between each product additio n. However, during m edia fill simulations, the operator aliquot(DJ(4J of media and tr·ansfer it between 4 b)( bags I (b )(4 ) I dispens ing into~{41 vials for in7lib ation. • During media fill simulations, operators dispense approximately (6 )(4 of m edia into 6 )(4 vials for incubation which does n ot represent final fill volume of your fnm ' s sterile diu g products. However, during actual production operations, operators fill prefill ed bags (rang ing from I ·col<4) I) or syrmges. EMPLOYEE(S) SI GNATURE DATE ISSUED SEE REVERSE De mari o L Wa lls , I n ve s t i g a t o r 6/ 4 /2026 OF THIS PAGE oen.loL Wl h ~ CIQWOOL w,,u_a . x ~rO&<lt-2ll26 PAGE8of!0 PAGES F ORM FDA ~83 ( 0

Observation 9 — Materials were exposed to lower than ISO 5 quality air. Specifically, on 5/28/2026, I

Materials were exposed to lower than ISO 5 quality air. Specifically, on 5/28/2026, I obser ved sterile wipes stored on a counter across fr om ISO 5 LAFH fbX.if j within the ISO 7 classified cleanroom. The wipes were open ed and exposed to ISO 7 air quality and were subsequently used to clean and disinfect the surfaces of the ISO 5 LA FH . According to sta ff, the wipes are stored in the ISO 7 enviro nment until contents are fully depleted. Dmg products aseptically produced on 5/ 28 /2026 inclu de but are n ot limited to • Daptomycin (Cubicin) 75 0 mg/NS 50 mL , Order ID: 84305997, BUD: 05 /30/2026 • Cefepime/Sodium Chloride 0.9% 50 mL, Batch: 052826FS1, BUD: 06/12/2026 • Bumetani de 3 mg in Dextrose 5% 50 mL, Order ID: 84299952, BUD: 05/29/2026 • Acyclovir 600 mg in Sodium Chlori de 0.9% 250 mL, Order ID: 8430131 9, BUD: 05/29/2026 • Iron Dextran 975 mg in Sodium Chloride 0.9%, Order ID: 84301224, BUD: 05/28/2026 On 5/29/2026, I observed sterile wipes stor ed in a cart adjacent to the ISO 5 LAFH in segregated compounding area (SCA) in the Oncology Phaimacy Suite. The wipes were open ed and exposed to unclassified air and were subsequently used to clean and disinfect the surfaces o

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.

Lt Col Luke Weather Jr Veterans Affairs Medical Center’s FDA history

Argus HQ has recorded 1 total FDA action tied to Lt Col Luke Weather Jr Veterans Affairs Medical Center: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.

Frequently asked questions

What is an FDA Form 483?: A Form FDA 483 lists an FDA investigator’s written observations at the close of a facility inspection, issued under section 704(b) of the Federal Food, Drug, and Cosmetic Act. It documents conditions the investigator judged may violate FDA regulations. A 483 is not an enforcement action or a final determination that a violation occurred.
Does this Form 483 mean Lt Col Luke Weather Jr Veterans Affairs Medical Center violated the law?: No. A Form 483 documents an investigator's observations only. FDA reviews the firm's written response and any corrective actions taken before deciding whether further action is warranted, and many 483s are closed without additional enforcement once a firm shows adequate correction.
What happens after a Form 483 is issued?: The firm typically has 15 business days to submit a written response describing planned corrections. FDA reviews that response, and unresolved or serious findings can lead to a Warning Letter, import alert, or other enforcement action, though many 483s are resolved without further FDA action.
Has Lt Col Luke Weather Jr Veterans Affairs Medical Center had other FDA inspection citations?: This is the only FDA action Argus HQ has on file for Lt Col Luke Weather Jr Veterans Affairs Medical Center so far. Argus ingests new FDA records daily.

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Full FDA history for Lt Col Luke Weather Jr Veterans Affairs Medical Center

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). June 4, 2026 FDA Form 483 for Lt Col Luke Weather Jr Veterans Affairs Medical Center — 6 Citations. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/483/lt-col-luke-weather-jr-veterans-affairs-medical-center-1074265-2026-06-04

MLA

"June 4, 2026 FDA Form 483 for Lt Col Luke Weather Jr Veterans Affairs Medical Center — 6 Citations." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/483/lt-col-luke-weather-jr-veterans-affairs-medical-center-1074265-2026-06-04.

Chicago

Argus HQ Research. "June 4, 2026 FDA Form 483 for Lt Col Luke Weather Jr Veterans Affairs Medical Center — 6 Citations." Digital Empire Holdings LLC. Accessed July 29, 2026. https://argushq.ai/483/lt-col-luke-weather-jr-veterans-affairs-medical-center-1074265-2026-06-04.

BibTeX

@misc{argushq_argushq_ai_483_lt_col_luke_weather_jr_veterans_affairs_medical_center_1074265_2026_06_04_2026,
  title = {June 4, 2026 FDA Form 483 for Lt Col Luke Weather Jr Veterans Affairs Medical Center — 6 Citations},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/483/lt-col-luke-weather-jr-veterans-affairs-medical-center-1074265-2026-06-04},
  note = {Accessed: July 29, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗