LIFETECH RESOURCES LLC
Form 483 issued March 3, 2025 · MOORPARK, California
- Inspection
- Feb 27 – Mar 3, 2025
- Investigator
- Christopher R. Czajka
- Observations
- 4
- Pages
- 4
- FEI number
- 3012681020
In short: On March 3, 2025, FDA issued a Form 483 with 4 observations to LIFETECH RESOURCES LLC in MOORPARK, California (FEI 3012681020) after an inspection that ran Feb 27 – Mar 3, 2025. The investigator was Christopher R. Czajka. Most observations concern quality system and packaging & labeling.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
Employees are not given training in the particular operations they perform as part of their function…
- 02
Strict control is not exercised over labeling issued for use in…
- 03
The reserve sample of active ingredient does not consist of at least twice the quantity necessary…
- 04
Drug products are not stored under appropriate conditions of temperature and humidity so that their identity…
This inspection in context
Christopher R. Czajka
37 documents · 2015–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
The firmLIFETECH RESOURCES LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.25(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at LIFETECH RESOURCES LLC?
FDA listed 4 observations on this Form 483, mostly about quality system, packaging & labeling and laboratory controls. The opening words of each observation are shown on this page.
Who inspected LIFETECH RESOURCES LLC?
Christopher R. Czajka is named on this Form 483, for the inspection of Feb 27 – Mar 3, 2025. Each investigator has a profile showing what they cite most.
When was LIFETECH RESOURCES LLC inspected by FDA?
The inspection ran Feb 27 – Mar 3, 2025, and the Form 483 is dated March 3, 2025.
How do I get the full Form 483 for LIFETECH RESOURCES LLC?
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.