ASCLEMED USA INC. DBA ENOVACHEM
Form 483 issued September 27, 2018 · Torrance, California
- Investigator
- Rumany C. Penn
- Observations
- 3
- Pages
- 3
- FEI number
- 3001452204
In short: On September 27, 2018, FDA issued a Form 483 with 3 observations to ASCLEMED USA INC. DBA ENOVACHEM in Torrance, California (FEI 3001452204). The investigator was Rumany C. Penn. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and quality system account for 2 of 3 observations.
Most cited: 21 CFR 211.68 (1×) · 211.180 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Routine calibration or checking of mechanical or electronic equipment is not performed according to a written…
- 02
Written procedures are not established for evaluations done at least annually and including provisions for a…
- 03
Certificates of Analyses (COAs) do not show the name and address of the original manufacturer or…
This inspection in context
Rumany C. Penn
21 documents · 2016–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmASCLEMED USA INC. DBA ENOVACHEM history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ASCLEMED USA INC. DBA ENOVACHEM?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected ASCLEMED USA INC. DBA ENOVACHEM?
Rumany C. Penn is named on this Form 483. Each investigator has a profile showing what they cite most.
When was ASCLEMED USA INC. DBA ENOVACHEM inspected by FDA?
This Form 483 is dated September 27, 2018.
How do I get the full Form 483 for ASCLEMED USA INC. DBA ENOVACHEM?
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.