Claris Injectables Limited Chacharwadi Vasna
Form 483 issued January 27, 2023 · Ahmedabad, India
- Inspection
- Jan 19 – Jan 27, 2023
- Investigators
- Justin A. Boyd· Pratik S. Upadhyay
- Observations
- 9
- Pages
- 19
- FEI number
- 3004610460
In short: On January 27, 2023, FDA issued a Form 483 with 9 observations to Claris Injectables Limited Chacharwadi Vasna in Ahmedabad, Gujarat (FEI 3004610460) after an inspection that ran Jan 19 – Jan 27, 2023. The investigators were Justin A. Boyd and Pratik S. Upadhyay. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Production and facilities & equipment account for 7 of 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
Observation 1: scanned text, readable in the full document.
- 02
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Justin A. Boyd
61 documents · 2010–2026
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 211.192
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 9 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Claris Injectables Limited Chacharwadi Vasna?
Justin A. Boyd and Pratik S. Upadhyay are named on this Form 483, for the inspection of Jan 19 – Jan 27, 2023. Each investigator has a profile showing what they cite most.
When was Claris Injectables Limited Chacharwadi Vasna inspected by FDA?
The inspection ran Jan 19 – Jan 27, 2023, and the Form 483 is dated January 27, 2023.
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.