Lowlite Investments, Inc. (dba Olympia Pharmacy)
Form 483 issued August 8, 2025 · Orlando, Florida
- Inspection
- Jul 28 – Aug 8, 2025
- Investigator
- Jose R. Lopez
- Observations
- 2
- Pages
- 5
- FEI number
- 3009724085
In short: On August 8, 2025, FDA issued a Form 483 with 2 observations to Lowlite Investments, Inc. (dba Olympia Pharmacy) in Orlando, Florida (FEI 3009724085) after an inspection that ran Jul 28 – Aug 8, 2025. The investigator was Jose R. Lopez. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
2 of 2 observations on this 483 concern production.
Most cited: 21 CFR 211.113(b) (1×) · 211.100(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of ding products purporting to be sterile did not include…
- 02
Yom firm failed to establish adequate written procedures for production and process controls designed to assure…
This inspection in context
Jose R. Lopez
7 documents · 2010–2026
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 211.113(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 2 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Lowlite Investments, Inc. (dba Olympia Pharmacy)?
Jose R. Lopez is named on this Form 483, for the inspection of Jul 28 – Aug 8, 2025. Each investigator has a profile showing what they cite most.
When was Lowlite Investments, Inc. (dba Olympia Pharmacy) inspected by FDA?
The inspection ran Jul 28 – Aug 8, 2025, and the Form 483 is dated August 8, 2025.
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.