Central Admixture Pharmacy Services, Inc.
Form 483 issued January 19, 2007 · Homewood, Alabama
- Inspection
- Jan 9 – Jan 19, 2007
- Investigators
- Clifton C. Francis· Marvin D. Jones
- Observations
- 13
- Pages
- 5
- FEI number
- 1000221951
In short: On January 19, 2007, FDA issued a Form 483 with 13 observations to Central Admixture Pharmacy Services, Inc. in Homewood, Alabama (FEI 1000221951) after an inspection that ran Jan 9 – Jan 19, 2007. The investigators were Clifton C. Francis and Marvin D. Jones. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.113 (3×) · 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
The designated quality control unit does not have the authority or responsibility to approve/reject raw materials…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Observation 3: scanned text, readable in the full document.
- 04
Batch production records do not include all lot numbers of raw ingredients that are used in…
This inspection in context
Clifton C. Francis
1 document · 2007
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Alabama.
The firmCentral Admixture Pharmacy Services, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
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 13 observations on this Form 483, mostly about production, quality system and materials. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Central Admixture Pharmacy Services, Inc.?
Clifton C. Francis and Marvin D. Jones are named on this Form 483, for the inspection of Jan 9 – Jan 19, 2007. Each investigator has a profile showing what they cite most.
When was Central Admixture Pharmacy Services, Inc. inspected by FDA?
The inspection ran Jan 9 – Jan 19, 2007, and the Form 483 is dated January 19, 2007.
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.