Elkhart Pharmacy
Form 483 issued December 21, 2015 · Elkhart, Texas
- Inspection
- Dec 14 – Dec 15, 2015
- Investigators
- Darla J. Christopher· Jason R. Caballero
- Observations
- 4
- Pages
- 4
- FEI number
- 3011870779
In short: On December 21, 2015, FDA issued a Form 483 with 4 observations to Elkhart Pharmacy in Elkhart, Texas (FEI 3011870779) after an inspection that ran Dec 14 – Dec 15, 2015. The investigators were Darla J. Christopher and Jason R. Caballero. 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 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 02
Protective apparel is not worn as necessary to protect…
- 03
Results of stability testing are not used…
- 04
Aseptic processing areas are deficient regarding systems for maintaining any equipment used. to…
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 firmElkhart Pharmacy 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(c)(10)(v)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Elkhart Pharmacy?
FDA listed 4 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 Elkhart Pharmacy?
Darla J. Christopher and Jason R. Caballero are named on this Form 483, for the inspection of Dec 14 – Dec 15, 2015. Each investigator has a profile showing what they cite most.
When was Elkhart Pharmacy inspected by FDA?
The inspection ran Dec 14 – Dec 15, 2015, and the Form 483 is dated December 21, 2015.
How do I get the full Form 483 for Elkhart Pharmacy?
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.