KENIL HEALTHCARE PRIVATE LIMITED
Form 483 issued December 11, 2024 · Mehsana, India
- Inspection
- Dec 5 – Dec 11, 2024
- Observations
- 16
- Pages
- 19
- FEI number
- 3022380309
In short: On December 11, 2024, FDA issued a Form 483 with 16 observations to KENIL HEALTHCARE PRIVATE LIMITED in Mehsana, India (FEI 3022380309) after an inspection that ran Dec 5 – Dec 11, 2024. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and laboratory controls account for 10 of 16 observations.
Most cited: 21 CFR 211.67 (2×) · 211.165 (2×)
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 are not in…
- 0221 CFR 211
Employees are not given training in the particular operations they perform as part of their function…
- 03
Batch production and control records are not prepared for each batch of drug product produced and…
- 04
Written production and process control procedures are not followed in the execution of production and process…
This inspection in context
Questions about this 483
What did FDA find at KENIL HEALTHCARE PRIVATE LIMITED?
FDA listed 16 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
When was KENIL HEALTHCARE PRIVATE LIMITED inspected by FDA?
The inspection ran Dec 5 – Dec 11, 2024, and the Form 483 is dated December 11, 2024.
How do I get the full Form 483 for KENIL HEALTHCARE PRIVATE LIMITED?
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.