Ionia Pharmacy
Form 483 issued March 6, 2015 · Tustin, California
- Inspection
- Mar 3 – Mar 6, 2015
- Investigators
- Binh T. Nguyen· Chelsea N. Sealey· Roger F. Zabinski
- Observations
- 10
- Pages
- 9
- FEI number
- 3011014614
In short: On March 6, 2015, FDA issued a Form 483 with 10 observations to Ionia Pharmacy in Tustin, California (FEI 3011014614) after an inspection that ran Mar 3 – Mar 6, 2015. The investigators were Binh T. Nguyen, Chelsea N. Sealey and Roger F. Zabinski. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
Production and laboratory controls account for 6 of 10 observations.
Most cited: 21 CFR 211.166 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system…
- 02
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 04
Protective apparel is not worn as necessary to protect…
This inspection in context
Binh T. Nguyen
13 documents · 2009–2016
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmIonia 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 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ionia Pharmacy?
FDA listed 10 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected Ionia Pharmacy?
Binh T. Nguyen, Chelsea N. Sealey and Roger F. Zabinski are named on this Form 483, for the inspection of Mar 3 – Mar 6, 2015. Each investigator has a profile showing what they cite most.
When was Ionia Pharmacy inspected by FDA?
The inspection ran Mar 3 – Mar 6, 2015, and the Form 483 is dated March 6, 2015.
How do I get the full Form 483 for Ionia 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.