Lowlite Investments, Inc. (dba Olympia Pharmacy)
Form 483 issued March 2, 2022 · Orlando, Florida
- Inspection
- Feb 14 – Mar 2, 2022
- Investigators
- Clinton J. Lott· Jessica P. McAlister· Susan O. Oladeji
- Observations
- 13
- Pages
- 20
- FEI number
- 3009724085
In short: On March 2, 2022, FDA issued a Form 483 with 13 observations to Lowlite Investments, Inc. (dba Olympia Pharmacy) in Orlando, Florida (FEI 3009724085) after an inspection that ran Feb 14 – Mar 2, 2022. The investigators were Clinton J. Lott, Jessica P. McAlister and Susan O. Oladeji. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.192 (3×) · 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Dmg products failing to meet established…
- 02
The quality control unit lacks responsibility to reject all procedures or specifications impacting on the identity…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency paiiiculate air…
This inspection in context
Clinton J. Lott
10 documents · 2021–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
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 211.192
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 13 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Lowlite Investments, Inc. (dba Olympia Pharmacy)?
Clinton J. Lott, Jessica P. McAlister and Susan O. Oladeji are named on this Form 483, for the inspection of Feb 14 – Mar 2, 2022. Each investigator has a profile showing what they cite most.
When was Lowlite Investments, Inc. (dba Olympia Pharmacy) inspected by FDA?
The inspection ran Feb 14 – Mar 2, 2022, and the Form 483 is dated March 2, 2022.
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.