Alkem Laboratories Ltd No. 8, Old National Highway at Naugama
Form 483 issued September 18, 2015 · Mandva, India
- Inspection
- Sep 14 – Sep 18, 2015
- Investigator
- Tamil Arasu
- Observations
- 1
- Pages
- 2
- FEI number
- 3008450172
In short: On September 18, 2015, FDA issued a Form 483 with 1 observation to Alkem Laboratories Ltd No. 8, Old National Highway at Naugama in Mandva, India (FEI 3008450172) after an inspection that ran Sep 14 – Sep 18, 2015. The investigator was Tamil Arasu. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (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 and checking of electronic equipment is not performed according to a written program designed…
This inspection in context
Tamil Arasu
27 documents · 2011–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmAlkem Laboratories Ltd No. 8, Old National Highway at Naugama history
The site's inspection history, in date order.
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 Alkem Laboratories Ltd No. 8, Old National Highway at Naugama?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. 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 Alkem Laboratories Ltd No. 8, Old National Highway at Naugama?
Tamil Arasu is named on this Form 483, for the inspection of Sep 14 – Sep 18, 2015. Each investigator has a profile showing what they cite most.
When was Alkem Laboratories Ltd No. 8, Old National Highway at Naugama inspected by FDA?
The inspection ran Sep 14 – Sep 18, 2015, and the Form 483 is dated September 18, 2015.
How do I get the full Form 483 for Alkem Laboratories Ltd No. 8, Old National Highway at Naugama?
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.