Central Admixture Pharmacy Services, Inc.
Form 483 issued December 4, 2015 · Livonia, Michigan
- Inspection
- Nov 16 – Dec 4, 2015
- Investigator
- Sarah M. Meng
- Observations
- 5
- Pages
- 4
- FEI number
- 1000306306
In short: On December 4, 2015, FDA issued a Form 483 with 5 observations to Central Admixture Pharmacy Services, Inc. in Livonia, Michigan (FEI 1000306306) after an inspection that ran Nov 16 – Dec 4, 2015. The investigator was Sarah M. Meng. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
3 of 5 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Clothing of personnel engaged in the processing of drug products is not appropriate for…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Sarah M. Meng
1 document · 2015
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Michigan.
The firmCentral Admixture Pharmacy Services, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
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 facilities & equipment and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Central Admixture Pharmacy Services, Inc.?
Sarah M. Meng is named on this Form 483, for the inspection of Nov 16 – Dec 4, 2015. Each investigator has a profile showing what they cite most.
When was Central Admixture Pharmacy Services, Inc. inspected by FDA?
The inspection ran Nov 16 – Dec 4, 2015, and the Form 483 is dated December 4, 2015.
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.