Key facts
| Firm | Central Admixture Pharmacy Services Inc |
|---|---|
| FEI / inspection ID | 3009590582 |
| Inspection end date | September 5, 2025 |
| Citation count | 5 |
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 — Procedures designed to prevent microbiological contamination of diu g products pmpo1ting to
Procedures designed to prevent microbiological contamination of diu g products pmpo1ting to be sterile are not fo llowed. Specifically, A. Your furn discontinued use of the [(6) -(4) Isystem in May 2025, which previously provided continuous non-viable particulate monitoring within ISO Class 5, 7, and 8 areas. Since discontinuation, over (o) (<t]batches have been manufactured using,[{65 the(6) (4) I particle counter as an alternative. Per SOP-CAPS-4000582, the ((6) (4) I collects only 6 (4) non-viable paiticulate samples per session, providing intennittent rather than continuous monitoring in ISO 5 areas where sterile di11g products are compounded. B. Per SOP-CAPS-4000710, each of the 4 lbH l ISO 7 compounding conidors is monitored only[(6) (4)] ~ for viable and non-viable pa1ticulates, despite active use across [(6) 4) I. Since Januaiy 2024, 4 7 alaim and action level excursions for viable CFU recoveries have been documented across ISO 7 air, surface, and personnel monitoring sainples.
Observation 2 — AM ENDM EN T 1 EMPLOYEE(S) SIGNATURE DATE ISSUED SEE REVERSE Seneca
AM ENDM EN T 1 EMPLOYEE(S) SIGNATURE DATE ISSUED SEE REVERSE Seneca D Toms, National Expert 9/5/2025 OF THIS PAGE SEnecaOTom& ~~&~.X 1 61)5;3 FORM FDA ~83 (09/08) PAGE I of6 PAGES PREVIOUS EDmON OBSOLEJE INSPECTIONAL OBSERVATIONS
Observation 3 — Testing and release of dmg product fo r distribution do n ot
Testing and release of dmg product fo r distribution do n ot include appropriate laborato1y dete1min ation of satisfacto1y con fo1m ance to the final specifications prior to release. Specifically, Your fnm's 100% visual inspection process is deficient. Since August 2024, there have been approximate b ly 94 cases of first Acceptable Quality Level (AQL) failures, primarily for paiticulates 4 ~(b) < and leaking bags 4 '(b) < ~) , and seven second AQL failures involving compounded aseptically filled products. The detection of visible paiticulate matter and leaking containers following your I 00% visual inspection demonstrates that the inspection program does not consistently detect product defects prior to release.
Observation 4 — Repo1ts of analysis from component suppliers are accepted in lieu of testing
Repo1ts of analysis from component suppliers are accepted in lieu of testing each component for con fo1mity with all appropriate written specifications, without peifo1ming at least one specific identity test on each component and establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals. Specifically, fucoming components and diu g product con tainers used in diug products compounded fo r intravenous administration ai·e not tested or inspected. Materials ai·e accepted based on the suppliers ce1tificate of analysis, without samp ling and examination. Examples of materials used without appropriate evaluation AM ENDMEN T 1
Observation 5 — There is a failure to thoroughly review any unexplained discrepancy whether or
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch h as been aheady distributed. Specifically, Your procedure SOP-CAPS-4000582 "Environmental Monitoring-503B" allows fo r non-viable paiiiculate (NVP) sample retesting without investigation fo llowing ale1i or action level excursions in ISO 5, 7, and 8 ai·eas. Specifically, Section 6.10.4.A states that no investigation is required if 5 4 < H l [6)(~) J NVP samples collected after an ale1i or action alaim fall below the excursion threshold at the same location. Since Januaiy 2025, your fom has documented 8 instances ofNVP excursion events where no investigations were initiated, instead relying on this retesting protocol. When questioned, your fnm explained that this resampling practice provides "a more representative snapshot of the environment." This practice allows potentially signifi cant environmental excursions to go uninvestigated by using retesting to oveITide initial ale1i and action level results. THIS OB SER VA TION WAS PREVIOUSLY CITED IN 2023 AM ENDMEN T.
Central Admixture Pharmacy Services, Inc.’s FDA history
Argus HQ has recorded 3 total FDA actions tied to Central Admixture Pharmacy Services, Inc.: 0 warning letters, 1 recall, 0 approval records, and 2 Form 483 inspection citations.
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 Central Admixture Pharmacy Services Inc 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 Central Admixture Pharmacy Services Inc had other FDA inspection citations?
- Yes. Argus HQ has recorded 3 total FDA actions tied to Central Admixture Pharmacy Services Inc, including 2 Form 483 inspection citations.
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Related enforcement actions
Full FDA history for Central Admixture Pharmacy Services, Inc.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.
Argus HQ Research (2025). Form 483 Record: Central Admixture Pharmacy Services Inc, September 5, 2025 — 5 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-central-admixture-pharmacy-services-inc-2025-09-05-3009590582
"Form 483 Record: Central Admixture Pharmacy Services Inc, September 5, 2025 — 5 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-central-admixture-pharmacy-services-inc-2025-09-05-3009590582.
Argus HQ Research. "Form 483 Record: Central Admixture Pharmacy Services Inc, September 5, 2025 — 5 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-central-admixture-pharmacy-services-inc-2025-09-05-3009590582.
@misc{argushq_argushq_ai_483_fda_483_central_admixture_pharmacy_services_inc_2025_09_05_3009590582_2025,
title = {Form 483 Record: Central Admixture Pharmacy Services Inc, September 5, 2025 — 5 Citations},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-central-admixture-pharmacy-services-inc-2025-09-05-3009590582},
note = {Accessed: July 15, 2026}
}