Lowlite Investments, Inc. (dba Olympia Pharmacy)
Form 483 issued September 3, 2026 · Orlando, Florida
- Inspection
- Aug 20 – Sep 3, 2026
- Investigators
- Michelle Lin· Mindy M. Chou
- Observations
- 8
- Pages
- 9
- FEI number
- 3009724085
In short: On September 3, 2026, FDA issued a Form 483 with 8 observations to Lowlite Investments, Inc. (dba Olympia Pharmacy) in Orlando, Florida (FEI 3009724085) after an inspection that ran Aug 20 – Sep 3, 2026. The investigators were Michelle Lin and Mindy M. Chou. 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 6 of 8 observations.
Most cited: 21 CFR 211.42 (2×) · 211.100 (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
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Written production and process control procedures are not followed in the execution of production and process…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Michelle Lin
1 document · 2026
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Florida.
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 211.42
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 8 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)?
Michelle Lin and Mindy M. Chou are named on this Form 483, for the inspection of Aug 20 – Sep 3, 2026. Each investigator has a profile showing what they cite most.
When was Lowlite Investments, Inc. (dba Olympia Pharmacy) inspected by FDA?
The inspection ran Aug 20 – Sep 3, 2026, and the Form 483 is dated September 3, 2026.
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.