Claris Injectables Limited Chacharwadi Vasna
Form 483 issued August 4, 2017 · Ahmedabad, India
- Inspection
- Jul 27 – Aug 4, 2017
- Investigators
- Massoud Motamed· Th J. Arista
- Observations
- 1
- Pages
- 17
- FEI number
- 3004610460
In short: On August 4, 2017, FDA issued a Form 483 with 1 observation to Claris Injectables Limited Chacharwadi Vasna in Ahmedabad, Gujarat (FEI 3004610460) after an inspection that ran Jul 27 – Aug 4, 2017. The investigators were Massoud Motamed and Th J. Arista. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.194 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Electronic records do not support the authenticity of environmental monitoring: a. ta does not support…
This inspection in context
Massoud Motamed
20 documents · 2015–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Texas.
The firmClaris Injectables Limited Chacharwadi Vasna history
All 9 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Claris Injectables Limited Chacharwadi Vasna?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Claris Injectables Limited Chacharwadi Vasna?
Massoud Motamed and Th J. Arista are named on this Form 483, for the inspection of Jul 27 – Aug 4, 2017. Each investigator has a profile showing what they cite most.
When was Claris Injectables Limited Chacharwadi Vasna inspected by FDA?
The inspection ran Jul 27 – Aug 4, 2017, and the Form 483 is dated August 4, 2017.
How do I get the full Form 483 for Claris Injectables Limited Chacharwadi Vasna?
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.