OPS International Incorporated dba Olympia Pharmacy
Form 483 issued December 4, 2014 · Orlando, Florida
- Inspection
- Dec 4, 2014
- Investigator
- Joanne E. King
- Observations
- 8
- Pages
- 6
- FEI number
- 3011158365
In short: On December 4, 2014, FDA issued a Form 483 with 8 observations to OPS International Incorporated dba Olympia Pharmacy in Orlando, Florida (FEI 3011158365) after an inspection that ran Dec 4, 2014. The investigator was Joanne E. King. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and laboratory controls account for 6 of 8 observations.
Most cited: 21 CFR 211.42 (4×)
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 systems for maintaining any equipment used to…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
The written stability testing…
This inspection in context
Joanne E. King
34 documents · 2013–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Florida.
The firmOPS International Incorporated dba Olympia Pharmacy history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at OPS International Incorporated dba Olympia Pharmacy?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. 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 OPS International Incorporated dba Olympia Pharmacy?
Joanne E. King is named on this Form 483, for the inspection of Dec 4, 2014. Each investigator has a profile showing what they cite most.
When was OPS International Incorporated dba Olympia Pharmacy inspected by FDA?
The inspection ran Dec 4, 2014, and the Form 483 is dated December 4, 2014.
How do I get the full Form 483 for OPS International Incorporated dba Olympia 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.