Key facts
| Firm | Central Admixture Pharmacy Services Inc |
|---|---|
| FEI / inspection ID | 3014307835 |
| Inspection end date | September 5, 2025 |
| Citation count | 7 |
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 — There is a failure to thoroughly review any unexplained discrepancy and the
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. Specifically, The firm has failed to ensure reliable and reproducible quality production of sterile drug products manufactured by admixture compounding of active ingredients into intravenous (IV) bags and syringes and released to market. The firm has reported recurring non-conformances (NC) and notice of quality events (NQE) from July 2023 to August 2025 for defective units of IV bag drug products. Defects include particulate matter in solution (PM-S), particulates embedded (PM-E), delamination of external layer of IV bag, uncapped or leaky IV injection ports, leaking bag, defective component, or damaged labels. A. From April 2024 -August 2025, over 212 out of 1096 non-conformances (20%) were for failed 1st or 2 nd Acceptable Quality Limit (AQL) visual inspection for particulate matter (PM-S and PM-E) inside the.
Observation 2 — Component testing is deficient in that each component is not tested for
Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality. Specifically, SEEREVERSE OF THIS PAGE EMPL OYEE(S) SI GNATURE Roger F Zabinski , National Expert Ho me ro W Agui l ar, Microbiologist DATE I SSUED 9/5/2025 PAGE 5 of 14 PAGES FORM flOA 433 (09/03)
Observation 3 — SEEREVERSE OF THIS PAGE EMPL OYEE(S) SI GNATURE Roger F Zabinski
SEEREVERSE OF THIS PAGE EMPL OYEE(S) SI GNATURE Roger F Zabinski , National Ex pe rt Ho me ro W Agui l ar, Micro b i o l og i s t DATE I SSUED 9/5/2025 PAGE 6 of 14 P AGES FORM flOA 433 (09/03)
Observation 4 — Written records of investigations into the failure of a batch or any
Written records of investigations into the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow- up. Specifically, Your firm failed to thoroughly investigate three lb) (4) icrobial Detection System sterility test failures (OOS-000 55 , OOS-00070, & OOS-00104) for Heparin 4000 units/1000 mL NS (NDC: 7022-1) between 04/2025 and 06/2025. Investigations into these discrepancies included review of materials used and employee interviews. The isolates recovered were identified as Bacillus circulans in April and Chaetomium globosum between 05 /2025 & 06/2025. The investigations failed to address any aspects downstream of production, but not limited to, visual inspection, sample chain of custody, and media sterility. OBS ERVATION 5 The responsibilities and procedures applicable to the quality control unit are not fully followed.
Observation 5 — Established standards, sampling plans and test procedures are not followed
Established standards, sampling plans and test procedures are not followed. Specifically, A. Per the firm' s management and non-conformance investigations, the firm's finished product visual inspection test procedure, SOP-CAPS-4000688, is deficient and not fully followed. This visual inspection test procedure, SOP-CAPS-4000688, states that inspectors will have inute break after utes of product inspection. DEV-001194 opened on 6/24/2025 considered changing the inspection time to 30 minutes with a 5 minute break, but the inspection procedure has not been updated. Non-conformance NC-10409, 7/02/2025, states that Heparin 4,000 SEEREVERSE OF THIS PAGE EMPL OYEE(S) SI GNATURE Roger F Zabinski , National Ex pe rt Homero W Aguilar, Microbiologist DATE I SSUED 9/5/2025 PAGE II of 14 PAGES FORM flOA 433 (09/03)
Observation 6 — Estab li shment of the reliability of the component supplier's report of
Estab li shment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals. Specifically, SEEREVERSE OF THIS PAGE EMPL OYEE(S) SI GNATURE Roger F Zabinski , National Expert Ho me ro W Agui l ar, Microbiologist DATE I SSUED 9/5/2025 PAGE 12 of 14 PAGES FORM flOA 433 (09/03)
Observation 7 — Aseptic processing areas are deficient regarding the system for monitoring environmental conditions
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. Specifically, The firm' s procedure SOP-CAPS-4000820, 7.0, 12/15/2024, (b) {4l ontinuous Environmental Monitoring System Operation is deficient in that it allows the use of manual non-viable and viable active air environmental monitoring equipment to be used in the event of a system failure for the lb) (4J Continuous EM monitoring. The manual non-viable and viable active air environmental morutonng equipment do not operate continuously and do not monitor the entire aseptic compounding operation. *DATES OF INSPECTION
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 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.
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3014307835.
- 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.
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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). FDA Inspects Central Admixture Pharmacy Services Inc: Form 483 with 7 Citations (September 5, 2025). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-central-admixture-pharmacy-services-inc-2025-09-05-3014307835
"FDA Inspects Central Admixture Pharmacy Services Inc: Form 483 with 7 Citations (September 5, 2025)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-central-admixture-pharmacy-services-inc-2025-09-05-3014307835.
Argus HQ Research. "FDA Inspects Central Admixture Pharmacy Services Inc: Form 483 with 7 Citations (September 5, 2025)." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-central-admixture-pharmacy-services-inc-2025-09-05-3014307835.
@misc{argushq_argushq_ai_483_fda_483_central_admixture_pharmacy_services_inc_2025_09_05_3014307835_2025,
title = {FDA Inspects Central Admixture Pharmacy Services Inc: Form 483 with 7 Citations (September 5, 2025)},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-central-admixture-pharmacy-services-inc-2025-09-05-3014307835},
note = {Accessed: July 15, 2026}
}