Claris Injectables Limited Chacharwadi Vasna
Form 483 issued May 17, 2022 · Ahmedabad, India
- Inspection
- May 9 – May 17, 2022
- Investigators
- Anastasia M. Shields· Jose E. Melendez
- Observations
- 7
- Pages
- 9
- FEI number
- 3004610460
In short: On May 17, 2022, FDA issued a Form 483 with 7 observations to Claris Injectables Limited Chacharwadi Vasna in Ahmedabad, Gujarat (FEI 3004610460) after an inspection that ran May 9 – May 17, 2022. The investigators were Anastasia M. Shields and Jose E. Melendez. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
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 211.22
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 7 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Claris Injectables Limited Chacharwadi Vasna?
Anastasia M. Shields and Jose E. Melendez are named on this Form 483, for the inspection of May 9 – May 17, 2022. Each investigator has a profile showing what they cite most.
When was Claris Injectables Limited Chacharwadi Vasna inspected by FDA?
The inspection ran May 9 – May 17, 2022, and the Form 483 is dated May 17, 2022.
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.