Martin Avenue Pharmacy, Inc.
Form 483 issued July 21, 2014 · Naperville, Illinois
- Inspection
- Jun 30 – Jul 21, 2014
- Investigator
- Russell K. Riley
- Observations
- 15
- Pages
- 9
- FEI number
- 3003381432
In short: On July 21, 2014, FDA issued a Form 483 with 15 observations to Martin Avenue Pharmacy, Inc. in Naperville, Illinois (FEI 3003381432) after an inspection that ran Jun 30 – Jul 21, 2014. The investigator was Russell K. Riley. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.94 (drug product containers and closures).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)
During a field examination ofdrug products at your fac ility…
- 02
Procedmes designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
Time limits are not established when appropriate for the completion of each production phase to assure…
- 04
Batch production and control records do not include complete information relating to the production and…
This inspection in context
Russell K. Riley
7 documents · 2013–2015
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Illinois.
The firmMartin Avenue 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 Martin Avenue Pharmacy, Inc.?
FDA listed 15 observations on this Form 483, mostly about facilities & equipment, materials and production. The most-cited regulation is 21 CFR 211.94 (drug product containers and closures). The opening words of each observation are shown on this page.
Who inspected Martin Avenue Pharmacy, Inc.?
Russell K. Riley is named on this Form 483, for the inspection of Jun 30 – Jul 21, 2014. Each investigator has a profile showing what they cite most.
When was Martin Avenue Pharmacy, Inc. inspected by FDA?
The inspection ran Jun 30 – Jul 21, 2014, and the Form 483 is dated July 21, 2014.
How do I get the full Form 483 for Martin Avenue 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.