Alchymars ICM SM Private Limited
Form 483 issued October 19, 2018 · Alathur, India
- Inspection
- Oct 15 – Oct 19, 2018
- Investigators
- Junho Pak· Unnee Ranjan
- Observations
- 11
- Pages
- 10
- FEI number
- 3005216842
In short: On October 19, 2018, FDA issued a Form 483 with 11 observations to Alchymars ICM SM Private Limited in Alathur, Tamil Nadu (FEI 3005216842) after an inspection that ran Oct 15 – Oct 19, 2018. The investigators were Junho Pak and Unnee Ranjan. 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 8 of 11 observations.
Most cited: 21 CFR 211.68 (4×) · 211.160 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Documented records were found to contain…
- 02
Employee training programs are…
- 03
Stability program is…
- 04
The firm’s chromatographic software, Agilent OpenLAB, is not configured to protect the integrity of the electronic…
This inspection in context
Junho Pak
28 documents · 2012–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmAlchymars ICM SM Private Limited history
All 4 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 Alchymars ICM SM Private Limited?
FDA listed 11 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. 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 Alchymars ICM SM Private Limited?
Junho Pak and Unnee Ranjan are named on this Form 483, for the inspection of Oct 15 – Oct 19, 2018. Each investigator has a profile showing what they cite most.
When was Alchymars ICM SM Private Limited inspected by FDA?
The inspection ran Oct 15 – Oct 19, 2018, and the Form 483 is dated October 19, 2018.
How do I get the full Form 483 for Alchymars ICM SM Private Limited?
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.