Lowlite Investments, Inc. (dba Olympia Pharmacy)
Form 483 issued March 21, 2013 · Orlando, Florida
- Inspection
- Mar 4 – Mar 21, 2013
- Investigators
- Brooke K. Higgins· Caryn M. McNab· Joanne E. King
- Observations
- 12
- Pages
- 7
- FEI number
- 3009724085
In short: On March 21, 2013, FDA issued a Form 483 with 12 observations to Lowlite Investments, Inc. (dba Olympia Pharmacy) in Orlando, Florida (FEI 3009724085) after an inspection that ran Mar 4 – Mar 21, 2013. The investigators were Brooke K. Higgins, Caryn M. McNab and Joanne E. King. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and facilities & equipment account for 8 of 12 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Brooke K. Higgins
5 documents · 2011–2014
Cites 211.42(c)(10) (design and construction features) more than any other section. Most of their documents are for sites in Maryland.
The firmLowlite Investments, Inc. (dba Olympia Pharmacy) history
All 6 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 Lowlite Investments, Inc. (dba Olympia Pharmacy)?
FDA listed 12 observations on this Form 483, mostly about production, facilities & equipment 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 Lowlite Investments, Inc. (dba Olympia Pharmacy)?
Brooke K. Higgins, Caryn M. McNab and Joanne E. King are named on this Form 483, for the inspection of Mar 4 – Mar 21, 2013. Each investigator has a profile showing what they cite most.
When was Lowlite Investments, Inc. (dba Olympia Pharmacy) inspected by FDA?
The inspection ran Mar 4 – Mar 21, 2013, and the Form 483 is dated March 21, 2013.
How do I get the full Form 483 for Lowlite Investments, Inc. (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.