Central Admixture Pharmacy Services, Inc. (CAPS)

Form 483 issued January 7, 2013 · Woburn, Massachusetts

Inspection: Jan 7, 2013
Investigators: Debra M. Emerson· Ramon E. Martinez· Stacey S. Degarmo
Observations: 15
Pages: 8
FEI number: 3004407863

In short: On January 7, 2013, FDA issued a Form 483 with 15 observations to Central Admixture Pharmacy Services, Inc. (CAPS) in Woburn, Massachusetts (FEI 3004407863) after an inspection that ran Jan 7, 2013. The investigators were Debra M. Emerson, Ramon E. Martinez and Stacey S. Degarmo. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).

At a glance

Facilities & equipment and production account for 10 of 15 observations.

Facilities & equipment6

Production4

Laboratory controls3

Quality system1

Other1

Most cited: 21 CFR 211.42 (4×) · 211.113 (3×)

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

01
21 CFR 211.167
The firm manufactures admixtures from commercially available finished products. The firm performs numerous manual aseptic manipulations…
02
21 CFR 211.113
There is a lack of microbial reduction/control steps in the manufacturing process…
03
21 CFR 211.192
Observation 3: scanned text, readable in the full document.
04
21 CFR 211.113 21 CFR 211.28
The environmental monitoring and conditions of the aseptic core are deficient…

11 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Debra M. Emerson

27 documents · 2008–2022

Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Massachusetts.

The firm

Central 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 483s

Other 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. (CAPS)?

FDA listed 15 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. 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)?

Debra M. Emerson, Ramon E. Martinez and Stacey S. Degarmo are named on this Form 483, for the inspection of Jan 7, 2013. Each investigator has a profile showing what they cite most.

When was Central Admixture Pharmacy Services, Inc. (CAPS) inspected by FDA?

The inspection ran Jan 7, 2013, and the Form 483 is dated January 7, 2013.

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.