Central Admixture Pharmacy Services, Inc. (CAPS)
Form 483 issued February 20, 2014 · Woburn, Massachusetts
- Inspection
- Feb 3 – Feb 20, 2014
- Investigators
- Camerson E. Moore· Edmund F. Mrak Jr
- Observations
- 10
- Pages
- 8
- FEI number
- 3004407863
In short: On February 20, 2014, FDA issued a Form 483 with 10 observations to Central Admixture Pharmacy Services, Inc. (CAPS) in Woburn, Massachusetts (FEI 3004407863) after an inspection that ran Feb 3 – Feb 20, 2014. The investigators were Camerson E. Moore and Edmund F. Mrak Jr. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
The operations relating to the processing and packing of penicillin are not performed in facilities separate…
- 02
Samples taken of drug products for determination of conformance to written…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have…
This inspection in context
Camerson E. Moore
48 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmCentral Admixture Pharmacy Services, Inc. (CAPS) history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Central Admixture Pharmacy Services, Inc. (CAPS)?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, laboratory controls 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. (CAPS)?
Camerson E. Moore and Edmund F. Mrak Jr are named on this Form 483, for the inspection of Feb 3 – Feb 20, 2014. Each investigator has a profile showing what they cite most.
When was Central Admixture Pharmacy Services, Inc. (CAPS) inspected by FDA?
The inspection ran Feb 3 – Feb 20, 2014, and the Form 483 is dated February 20, 2014.
How do I get the full Form 483 for Central Admixture Pharmacy Services, Inc. (CAPS)?
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.