Key facts
| Firm | VA San Diego Healthcare Systems |
|---|---|
| FEI / inspection ID | 2071629 |
| Inspection end date | May 8, 2026 |
| Citation count | 11 |
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 — Smoke studies were inadequately performed under dynamic conditions
Smoke studies were inadequately performed under dynamic conditions. Specifically, Your firm did not conduct smoke studies under dynamic conditions, simulating worst-case production activities, including all components, materials, and equipment present during actual or routine aseptic operations, to demonstrate unidirectional airflow within the ISO 5 area(s) for the following equipment: 04/08/2026 - Hazardous ~(o} (4~ - Biologic Safety Cabinets (BSC) - SN: OC.!~.f!~) J 03 / 11/2026 - Non-Hazardous ~ ) - Laminar Flow Hood (LAFH) - SN16J (4 ) ='------I , and[(l5) (4) I 04/23/2026- Operating Room (OR) Segregated ~ o) (4 D - Compounding Aseptic[(6) (4 )1 ~(b) (4) - 1 SN:[(b )(4 ) I 04/23/2026 - Intensive Care Unit (ICU) Segregated (o) (4 Y) - Compounding Aseptic[(6f(4 )7 (o} (4) - SN: 1(15) (4) I Add Continuation Page
Observation 2 — Beta-lactam drugs were produced without providing adequate containment, segregation, and/or cleaning of
Beta-lactam drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination. Specifically, Beta-Lactam drug products are produced in the same ISO 5 hoods as non-beta-lactam drug products intended to be sterile. The following beta-lactam drugs were observed being produced in your LAFH hood include, but are not limited to: - - - - - - ceftaroline fosamil 300 mg in D5W 100 mL ampicillin 2 gm in Normal Saline Mini-Bag 100 mL ampicillin/sulbactam 3 gm in Normal Saline Mini-Bag I 00 mL ertapenem I gm in Normal Saline Mini-Bag 50 mL meropenem 1000 mg in Normal Saline Mini-Bag 50 mL meropenem 2000 mg in Normal Saline 100 mL Your firm performs cleaning with only '( bl <41 between the production of beta-lactam and non-beta lactam drug products intended to be sterile in the same ISO 5 area and uses [(I:)) (4) I, with a [(I:)) (4) I~ time, as the cleaning/sanitizing.
Observation 3 — Contamination was observed in your production area
Contamination was observed in your production area. Specifically, On 04/29/2026, unidentified brown staining was observed on the HEPA filter in the ISO 5 non-hazardous LAFH production hood (SN: [(o) (4) I Your firm was unable to identify the source of the staining or confirm whether it affected filter integrity, air quality, or aseptic conditions in the ISO 5 area. The duration of this condition is unknown. Add Continuation Page
Observation 4 — Lack of disinfection of supplies at each transition from areas of lower
Lack of disinfection of supplies at each transition from areas of lower quality air to areas of higher quality air. Specifically, A) On 04/27/2026, 04/28/2026, and 04/29/2026, 4 '(bl < I operators in both the hazardous and non-hazardous production rooms failed to wipe down materials with an appropriate disinfectant (e.g., [(I)) (4) when transitioning those materials from the ISO 7 buffer room environment into the ISO 5 critical zone during the production of luspatercept aamt 50mg, label #L( e)]~ ) I- B) On 04/28/2026, a re-purposed [( lj ) (4)i bottle, labeled ' (b) (4) I used to discard leftover fluid generated during aseptic processing operations, was observed used within the ISO 5 critical zone without observed disinfection upon transfer from the ISO 7 buffer room after being emptied. The bottle was reused and stored in the ISO 5 hood over multiple days. During aseptic processing activities, the cap has to be removed by the technician, and the bottle handled.
Observation 5 — An operator rested their arms on the work surface of the hood
An operator rested their arms on the work surface of the hood during aseptic production. This practice may introduce contamination into the ISO 5 work area. Specifically, A) In the non-hazardous production room (6) (4) operators were observed resting their hands directly on the ISO 5 workbench surface on 04/29/2026 during the production of micafungin 100mg in normal saline 1OOmL. B) On 04/28/2026, the operator's elbows were observed resting on the edge of the front grille of the ISO 5 Biological Safety Cabinet (BSC). Add Continuation Page
Observation 6 — Personnel were observed touching equipment or other surfaces located outside of the
Personnel were observed touching equipment or other surfaces located outside of the ISO 5 area with gloved hands and then proceeding with aseptic processing without changing or sanitizing gloves. Specifically, On 04/28/2026 during the production of bortezomib 2.7mg, label #L(~ )]~) Ian operator failed to sanitize or change their gloved hands with [(6) (4) I after touching the computer keyboard and mouse within the ISO 7 buffer room prior to going back into the ISO 5 critical area to continue aseptically processing drug product intended to be sterile. Your SOP only specifies[(o) (4) I surfaces. We did not observe your third party cleaners cleaning and sanitizing your keyboards, mouse, and handheld scanner. Add Continuation Page
Observation 7 — STREET ADDRESS DATE(S) OF INSPECTION 4/27/26-5/1/26, 5/4/26-5/6/26, 5/8/26 FEI NUMBER 2071629 3350
STREET ADDRESS DATE(S) OF INSPECTION 4/27/26-5/1/26, 5/4/26-5/6/26, 5/8/26 FEI NUMBER 2071629 3350 La Jolla Village Dr TYPE OF ESTABLISHMENT INSPECTED Producer of Sterile Drug Products Personnel were observed moving quickly in a critical area or in an area immediately adjacent to a critical area likely causing disruption of unidirectional airflow. Specifically, An operator was observed spraying their gloved hands with (bl <4> under the ISO 5 hood and then rapidly moved their hands to dry within the critical area, causing disruption of unidirectional airflow on 04/28/2026 during the production of bortezomib 2.7mg, label li(o) (4) The operator's hands moved rapidly over materials and components used during production. SEE REVERSE OF THIS PAGE
Observation 8 — Production areas have difficult to clean or contain porous, particle generating, or
Production areas have difficult to clean or contain porous, particle generating, or visibly dirty equipment or surfaces. Specifically, A) The~ l:5 ) (4)plate and washer located on the front grille of BSC SN: [(6) (4) and [(15) (4)] (hazardous room (b) <4 l) are difficult to clean and may harbor and shed particulates and microbial contamination into the ISO 5 environment. This screw and washer were left by the firm's engineering to the BSC grill and not part of the smoke studies, therefore there is no assurance that this is not interfering in the functionality or causing turbulence in the BSC. B) On 04/30/2026, during the production of doxorubicin 48mg in normal saline 250 mL, chipped and protruding paint was observed on the walls of the ISO 7 buffer room. C) At least~bl <4 j protruding fire sprinklers located in the ISO 7 ante and buffer rooms were observed not cleaned since around 2020. Additionally, the screw, cameras, and WiFi.
Observation 9 — Personnel performed aseptic manipulations with exposed hair or skin
Personnel performed aseptic manipulations with exposed hair or skin. Specifically, A) On 04/27/2026 and 04/29/2026, multiple operators were observed aseptically processing drug products intended to be sterile in the ISO 5 laminar airflow hood (LAFH) with exposed hair, including during the production of daptomycin 670 mg in sodium chloride 0.9%, 36.6 mL, label #1 (15) (4) I in room (6) (4) B) On 04/29/2026, one operator was observed inserting their head, including the exposed skin of their forehead, and eyeglasses into the ISO 5 critical zone during the production of luspatercept-aamt 50mg, label ( (~ )]4) I- These eyeglasses are only cleaned with 4 (bl ( Y before being brought into the ISO 7 buffer area and are worn throughout the hospital and patient care areas. No sporicidal agent was used to clean these items and no environmental monitoring was performed to assess the contamination risk they may introduce. Add Continuation Page
Observation 10 — Materials were exposed to lower than ISO 5 quality air
Materials were exposed to lower than ISO 5 quality air. Specifically, A) Sterile, lint-fre.e wipes stored in an exposed, open condition were ob served on the wall of the ISO 7 buffer rooms. At leastM (4J of the transparent boxes on the wall had broken hinges and were left open during production. The wipes, which were difficult to pull from the box, were sprayed with ster il e 4 (bl < > in the ISO 7 buffer and then used to clean the ISO 5 workbench surface and to wipe materials transitioning from areas of lower quality air into the ISO 5 critical areas. B) Sterile, lint-free wipes were observed on the wall of the unclassified areas of the segregated ICU room ~(o) (4 )1 by the sink. Add Continuation Page EM PLOYEE(S) SI GNA TURE EM PLOYEE(S} NAME A ND TITLE (Print or Type) DATE ISSUED SEE REVERSE Ce cil ia H. Ki eu -5 ~.~~~~J!9; s~sbr3~~:;;~7~;-s Cecilia H..
Observation 11 — STREET ADDRESS 4/27/26-5/1/26, 5/4/26-5/6/26, 5/8/26 FEI NUMBER 2071629 3350 La Jolla Village
STREET ADDRESS 4/27/26-5/1/26, 5/4/26-5/6/26, 5/8/26 FEI NUMBER 2071629 3350 La Jolla Village Dr TYPE OF ESTABLISHMENT INSPECTED Producer of Sterile Drug Products Personnel engaged in aseptic processing were observed wearing non-sterile gloves. Specifically, Operators were observed using expired sterile gloves (manufactured in 01/2022) during aseptic production of bortezomib 2.7mg, label #l(eH�) ! on 04/28/2026. There is no assurance that the gloves are intact and remain sterile. Your sterile glove manufacturer suggested that the gloves be used within!..,____,_ (l5) 4_._ ) ___. I of the manufacturer date . Add Continuation Page SEE REVERSE OF THIS PAGE
VA San Diego Healthcare Systems’s FDA history
Argus HQ has recorded 1 total FDA action tied to VA San Diego Healthcare Systems: 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 VA San Diego Healthcare Systems 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 VA San Diego Healthcare Systems had other FDA inspection citations?
- This is the only FDA action Argus HQ has on file for VA San Diego Healthcare Systems so far. Argus ingests new FDA records daily.
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Related enforcement actions
Full FDA history for VA San Diego Healthcare SystemsCompiled 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.
Argus HQ Research (2026). FDA Inspects VA San Diego Healthcare Systems: Form 483 with 11 Citations (May 8, 2026). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-va-san-diego-healthcare-systems-2026-05-08-2071629
"FDA Inspects VA San Diego Healthcare Systems: Form 483 with 11 Citations (May 8, 2026)." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/483/fda-483-va-san-diego-healthcare-systems-2026-05-08-2071629.
Argus HQ Research. "FDA Inspects VA San Diego Healthcare Systems: Form 483 with 11 Citations (May 8, 2026)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-va-san-diego-healthcare-systems-2026-05-08-2071629.
@misc{argushq_argushq_ai_483_fda_483_va_san_diego_healthcare_systems_2026_05_08_2071629_2026,
title = {FDA Inspects VA San Diego Healthcare Systems: Form 483 with 11 Citations (May 8, 2026)},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-va-san-diego-healthcare-systems-2026-05-08-2071629},
note = {Accessed: July 13, 2026}
}