Lowlite Investments, Inc. (dba Olympia Pharmacy)
Form 483 issued May 29, 2024 · Orlando, Florida
- Inspection
- May 14 – May 29, 2024
- Investigators
- Jessica P. McAlister· Kayla V. Sprague· Libia M. Lugo
- Observations
- 7
- Pages
- 7
- FEI number
- 3009724085
In short: On May 29, 2024, FDA issued a Form 483 with 7 observations to Lowlite Investments, Inc. (dba Olympia Pharmacy) in Orlando, Florida (FEI 3009724085) after an inspection that ran May 14 – May 29, 2024. The investigators were Jessica P. McAlister, Kayla V. Sprague, Libia M. Lugo and Logan T. Williams. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Drug products failing to meet established…
- 02
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Jessica P. McAlister
7 documents · 2021–2024
Cites FDCA 501(a)(2)(A) (insanitary conditions) 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 211.165(f)
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 7 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)?
Jessica P. McAlister, Kayla V. Sprague, Libia M. Lugo and Logan T. Williams are named on this Form 483, for the inspection of May 14 – May 29, 2024. Each investigator has a profile showing what they cite most.
When was Lowlite Investments, Inc. (dba Olympia Pharmacy) inspected by FDA?
The inspection ran May 14 – May 29, 2024, and the Form 483 is dated May 29, 2024.
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.