Central Admixture Pharmacy Services, Inc. (CAPS)

Form 483 issued September 11, 2018 · San Diego, California

Inspection: Aug 27 – Sep 11, 2018
Investigator: Joey V. Quitania
Observations: 6
Pages: 4
FEI number: 3004378804

In short: On September 11, 2018, FDA issued a Form 483 with 6 observations to Central Admixture Pharmacy Services, Inc. (CAPS) in San Diego, California (FEI 3004378804) after an inspection that ran Aug 27 – Sep 11, 2018. The investigator was Joey V. Quitania. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).

At a glance

Production and facilities & equipment account for 4 of 6 observations.

Production2

Facilities & equipment2

Materials1

Laboratory controls1

What FDA observed

Preview: the opening words of each observation

01
21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be…
02
21 CFR 211.42(c)(10)
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic…
03
21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system…
04
21 CFR 211.80(a)
Written procedures are lacking which describe in sufficient detail the receipt of components, drug…

2 more observations

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

Get the full 483

This inspection in context

The investigator

Joey V. Quitania

23 documents · 2009–2026

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

The firm

Central Admixture Pharmacy Services, Inc. (CAPS) history

All 5 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.113(b)

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 6 observations on this Form 483, mostly about production, facilities & equipment and materials. 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)?

Joey V. Quitania is named on this Form 483, for the inspection of Aug 27 – Sep 11, 2018. Each investigator has a profile showing what they cite most.

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

The inspection ran Aug 27 – Sep 11, 2018, and the Form 483 is dated September 11, 2018.

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.