Claris Injectables Limited Chacharwadi Vasna
Form 483 issued August 26, 2016 · Ahmedabad, India
- Inspection
- Aug 16 – Aug 26, 2016
- Investigators
- Anastasia M. Shields· Angela E. Glenn
- Observations
- 1
- Pages
- 5
- FEI number
- 3004610460
In short: On August 26, 2016, FDA issued a Form 483 with 1 observation to Claris Injectables Limited Chacharwadi Vasna in Ahmedabad, Gujarat (FEI 3004610460) after an inspection that ran Aug 16 – Aug 26, 2016. The investigators were Anastasia M. Shields and Angela E. Glenn. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Anastasia M. Shields
45 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
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 211.100
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 production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Claris Injectables Limited Chacharwadi Vasna?
Anastasia M. Shields and Angela E. Glenn are named on this Form 483, for the inspection of Aug 16 – Aug 26, 2016. Each investigator has a profile showing what they cite most.
When was Claris Injectables Limited Chacharwadi Vasna inspected by FDA?
The inspection ran Aug 16 – Aug 26, 2016, and the Form 483 is dated August 26, 2016.
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.