LIFETECH RESOURCES LLC
Form 483 issued April 5, 2019 · MOORPARK, California
- Inspection
- Mar 27 – Apr 5, 2019
- Investigator
- Alan L. Truong
- Observations
- 2
- Pages
- 3
- FEI number
- 3012681020
In short: On April 5, 2019, FDA issued a Form 483 with 2 observations to LIFETECH RESOURCES LLC in MOORPARK, California (FEI 3012681020) after an inspection that ran Mar 27 – Apr 5, 2019. The investigator was Alan L. Truong. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.67(b) (1×) · 211.180(e) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
- 02
Records are not maintained so that data therein can be reviewed at least annually to evaluate…
This inspection in context
Alan L. Truong
16 documents · 2019–2025
Cites 211.188 (batch production and control records) 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 211.67(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at LIFETECH RESOURCES LLC?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected LIFETECH RESOURCES LLC?
Alan L. Truong is named on this Form 483, for the inspection of Mar 27 – Apr 5, 2019. Each investigator has a profile showing what they cite most.
When was LIFETECH RESOURCES LLC inspected by FDA?
The inspection ran Mar 27 – Apr 5, 2019, and the Form 483 is dated April 5, 2019.
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.