Walgreens Infusion Services
Form 483 issued November 25, 2014 · Houston, Texas
- Inspection
- Nov 4 – Nov 25, 2014
- Investigators
- Darla J. Christopher· Jason R. Caballero
- Observations
- 7
- Pages
- 4
- FEI number
- 3011074473
In short: On November 25, 2014, FDA issued a Form 483 with 7 observations to Walgreens Infusion Services in Houston, Texas (FEI 3011074473) after an inspection that ran Nov 4 – Nov 25, 2014. The investigators were Darla J. Christopher and Jason R. Caballero. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.28 (personnel responsibilities).
At a glance
Production and facilities & equipment account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Adequate exhaust systems or other systems to control contaminants are lacking in areas where air…
- 02
Written procedures for sanitation…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 04
Established sampling plans are not followed and documented at…
This inspection in context
Darla J. Christopher
10 documents · 2010–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmWalgreens Infusion Services history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.46(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Walgreens Infusion Services?
FDA listed 7 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.28 (personnel responsibilities). The opening words of each observation are shown on this page.
Who inspected Walgreens Infusion Services?
Darla J. Christopher and Jason R. Caballero are named on this Form 483, for the inspection of Nov 4 – Nov 25, 2014. Each investigator has a profile showing what they cite most.
When was Walgreens Infusion Services inspected by FDA?
The inspection ran Nov 4 – Nov 25, 2014, and the Form 483 is dated November 25, 2014.
How do I get the full Form 483 for Walgreens Infusion Services?
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.