Lowlite Investments, Inc. (dba Olympia Pharmacy)
Form 483 issued April 13, 2018 · Orlando, Florida
- Inspection
- Apr 6 – Apr 13, 2018
- Investigator
- Camerson E. Moore
- Observations
- 10
- Pages
- 9
- FEI number
- 3009724085
In short: On April 13, 2018, FDA issued a Form 483 with 10 observations to Lowlite Investments, Inc. (dba Olympia Pharmacy) in Orlando, Florida (FEI 3009724085) after an inspection that ran Apr 6 – Apr 13, 2018. The investigator was Camerson E. Moore. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Protective apparel is not worn as necessary to protect…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Camerson E. Moore
48 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
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 211.28(a)
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 10 observations on this Form 483, mostly about facilities & equipment, production and packaging & labeling. 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)?
Camerson E. Moore is named on this Form 483, for the inspection of Apr 6 – Apr 13, 2018. Each investigator has a profile showing what they cite most.
When was Lowlite Investments, Inc. (dba Olympia Pharmacy) inspected by FDA?
The inspection ran Apr 6 – Apr 13, 2018, and the Form 483 is dated April 13, 2018.
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.