Central Admixture Pharmacy Services, Inc.
Form 483 issued June 25, 2014 · Livonia, Michigan
- Inspection
- Jun 25, 2014
- Investigators
- Jeffrey D. Meng· Michele L. Forster
- Observations
- 3
- Pages
- 4
- FEI number
- 1000306306
In short: On June 25, 2014, FDA issued a Form 483 with 3 observations to Central Admixture Pharmacy Services, Inc. in Livonia, Michigan (FEI 1000306306) after an inspection that ran Jun 25, 2014. The investigators were Jeffrey D. Meng and Michele L. Forster. Most observations concern quality system and production.
At a glance
Quality system and production account for 2 of 3 observations.
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 whether or not the batch…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
The operations relating to the processing of penicillin are not performed in facilities separate from those…
This inspection in context
Jeffrey D. Meng
14 documents · 2010–2016
Cites 211.192 (production record review) 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 211.192
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 3 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Central Admixture Pharmacy Services, Inc.?
Jeffrey D. Meng and Michele L. Forster are named on this Form 483, for the inspection of Jun 25, 2014. Each investigator has a profile showing what they cite most.
When was Central Admixture Pharmacy Services, Inc. inspected by FDA?
The inspection ran Jun 25, 2014, and the Form 483 is dated June 25, 2014.
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.