Central Admixture Pharmacy Services
Form 483 issued July 31, 2023 · Phoenix, Arizona
- Inspection
- Jun 21 – Jul 31, 2023
- Investigators
- Dogbeda F. Mackenzie· June P. Page
- Observations
- 17
- Pages
- 28
- FEI number
- 3014307835
In short: On July 31, 2023, FDA issued a Form 483 with 17 observations to Central Admixture Pharmacy Services in Phoenix, Arizona (FEI 3014307835) after an inspection that ran Jun 21 – Jul 31, 2023. The investigators were Dogbeda F. Mackenzie and June P. Page. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in…
- 04
Drug product production and control records, are not reviewed and approved by the quality control unit…
This inspection in context
Dogbeda F. Mackenzie
14 documents · 2021–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmCentral Admixture Pharmacy Services history
All 4 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?
FDA listed 17 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. 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?
Dogbeda F. Mackenzie and June P. Page are named on this Form 483, for the inspection of Jun 21 – Jul 31, 2023. Each investigator has a profile showing what they cite most.
When was Central Admixture Pharmacy Services inspected by FDA?
The inspection ran Jun 21 – Jul 31, 2023, and the Form 483 is dated July 31, 2023.
How do I get the full Form 483 for Central Admixture Pharmacy Services?
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.