Central Admixture Pharmacy Services, Inc.
Form 483 issued September 5, 2025 · Allentown, Pennsylvania
- Inspection
- Aug 18 – Sep 5, 2025
- Investigator
- Seneca Toms
- Observations
- 5
- Pages
- 7
- FEI number
- 3009590582
In short: On September 5, 2025, FDA issued a Form 483 with 5 observations to Central Admixture Pharmacy Services, Inc. in Allentown, Pennsylvania (FEI 3009590582) after an inspection that ran Aug 18 – Sep 5, 2025. The investigator was Seneca Toms. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and production account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
The accuracy, sensitivity, specificity and reproducibility of test methods have not…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
This inspection in context
Seneca Toms
17 documents · 2013–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in North Carolina.
The firmCentral Admixture Pharmacy Services, Inc. history
All 8 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Central Admixture Pharmacy Services, Inc.?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, production and materials. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Central Admixture Pharmacy Services, Inc.?
Seneca Toms is named on this Form 483, for the inspection of Aug 18 – Sep 5, 2025. Each investigator has a profile showing what they cite most.
When was Central Admixture Pharmacy Services, Inc. inspected by FDA?
The inspection ran Aug 18 – Sep 5, 2025, and the Form 483 is dated September 5, 2025.
How do I get the full Form 483 for Central Admixture Pharmacy Services, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.