Central Admixture Pharmacy Services, Inc.
Form 483 issued March 30, 2023 · Allentown, Pennsylvania
- Inspection
- Feb 27 – Mar 30, 2023
- Investigator
- Jazmine N. Brown
- Observations
- 6
- Pages
- 7
- FEI number
- 3009590582
In short: On March 30, 2023, FDA issued a Form 483 with 6 observations to Central Admixture Pharmacy Services, Inc. in Allentown, Pennsylvania (FEI 3009590582) after an inspection that ran Feb 27 – Mar 30, 2023. The investigator was Jazmine N. Brown. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 4 of 6 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test…
- 04
Each batch of drug product purporting to be sterile is not laboratory tested to determine…
This inspection in context
Jazmine N. Brown
14 documents · 2022–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Pennsylvania.
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 211.192
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 6 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Central Admixture Pharmacy Services, Inc.?
Jazmine N. Brown is named on this Form 483, for the inspection of Feb 27 – Mar 30, 2023. Each investigator has a profile showing what they cite most.
When was Central Admixture Pharmacy Services, Inc. inspected by FDA?
The inspection ran Feb 27 – Mar 30, 2023, and the Form 483 is dated March 30, 2023.
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.