FDA Intel

Walgreens Home Care, Inc. dba Walgreens Infusion Services

Form 483 issued August 6, 2015 · San Antonio, Texas

Inspection
Jul 20 – Aug 6, 2015
Investigators
Jason R. Caballero· Lisa R. Jennings
Observations
6
Pages
6
FEI number
3011536648

In short: On August 6, 2015, FDA issued a Form 483 with 6 observations to Walgreens Home Care, Inc. dba Walgreens Infusion Services in San Antonio, Texas (FEI 3011536648) after an inspection that ran Jul 20 – Aug 6, 2015. The investigators were Jason R. Caballero and Lisa R. Jennings. 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 5 of 6 observations.

Facilities & equipment3
Production2
Laboratory controls1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.56(a)

    Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in…

  2. 02
    21 CFR 211.28(a)

    Protective apparel is not worn as necessary to protect…

  3. 03
    21 CFR 211.113(b)

    Procedures designed to prevent microbiological contamination of drug products purporting to be sterile…

  4. 04
    21 CFR 211.42(c)(10)(iv)

    Aseptic processing areas are deficient regarding the system…

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

Jason R. Caballero

26 documents · 2014–2020

Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.

The firm

Walgreens Home Care, Inc. dba Walgreens Infusion Services history

The site's inspection history, in date order.

Similar 483s

Other sites cited under 211.56(a)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Walgreens Home Care, Inc. dba Walgreens Infusion Services?

FDA listed 6 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 Walgreens Home Care, Inc. dba Walgreens Infusion Services?

Jason R. Caballero and Lisa R. Jennings are named on this Form 483, for the inspection of Jul 20 – Aug 6, 2015. Each investigator has a profile showing what they cite most.

When was Walgreens Home Care, Inc. dba Walgreens Infusion Services inspected by FDA?

The inspection ran Jul 20 – Aug 6, 2015, and the Form 483 is dated August 6, 2015.

How do I get the full Form 483 for Walgreens Home Care, Inc. dba Walgreens Infusion Services?

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