Eastern Pharmacy, Inc.
Form 483 issued February 4, 2014 · Ocala, Florida
- Inspection
- Jan 30 – Feb 4, 2014
- Investigators
- Carla A. Norris· Michael H. Tollon
- Observations
- 7
- Pages
- 4
- FEI number
- 3010633613
In short: On February 4, 2014, FDA issued a Form 483 with 7 observations to Eastern Pharmacy, Inc. in Ocala, Florida (FEI 3010633613) after an inspection that ran Jan 30 – Feb 4, 2014. The investigators were Carla A. Norris and Michael H. Tollon. Most observations concern production and quality system.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established…
- 02
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic…
- 03
Employees engaged in the processing and packing of'a drug product lack the education, training, and experience…
- 04
Each batch of drug product purporting to-be sterile is not laboratory tested to determine…
This inspection in context
Carla A. Norris
3 documents · 2013–2014
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Florida.
The firmEastern Pharmacy, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Eastern Pharmacy, Inc.?
FDA listed 7 observations on this Form 483, mostly about production, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Eastern Pharmacy, Inc.?
Carla A. Norris and Michael H. Tollon are named on this Form 483, for the inspection of Jan 30 – Feb 4, 2014. Each investigator has a profile showing what they cite most.
When was Eastern Pharmacy, Inc. inspected by FDA?
The inspection ran Jan 30 – Feb 4, 2014, and the Form 483 is dated February 4, 2014.
How do I get the full Form 483 for Eastern Pharmacy, Inc.?
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.