Zenara Pharma Private Limited
Form 483 issued January 20, 2023 · Hyderabad, India
- Inspection
- Jan 16 – Jan 20, 2023
- Observations
- 1
- Pages
- 2
- FEI number
- 3005485158
In short: On January 20, 2023, FDA issued a Form 483 with 1 observation to Zenara Pharma Private Limited in Hyderabad, Telangana (FEI 3005485158) after an inspection that ran Jan 16 – Jan 20, 2023. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
This inspection in context
Questions about this 483
What did FDA find at Zenara Pharma Private Limited?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. 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 Zenara Pharma Private Limited inspected by FDA?
The inspection ran Jan 16 – Jan 20, 2023, and the Form 483 is dated January 20, 2023.
How do I get the full Form 483 for Zenara Pharma 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.