Zenara Pharma Private Limited
Form 483 issued December 20, 2019 · Hyderabad, India
- Inspection
- Dec 16 – Dec 20, 2019
- Investigators
- Anitha P. Govada· Jose E. Melendez
- Observations
- 9
- Pages
- 10
- FEI number
- 3005485158
In short: On December 20, 2019, FDA issued a Form 483 with 9 observations to Zenara Pharma Private Limited in Hyderabad, Telangana (FEI 3005485158) after an inspection that ran Dec 16 – Dec 20, 2019. The investigators were Anitha P. Govada and Jose E. Melendez. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 7 of 9 observations.
Most cited: 21 CFR 211.192 (2×) · 211.186 (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…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 04
The written stability testing…
This inspection in context
Anitha P. Govada
1 document · 2019
Cites 211.186 (master production and control records) more than any other section. Most of their documents are for sites in India.
The firmZenara Pharma Private Limited history
All 2 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 Zenara Pharma Private Limited?
FDA listed 9 observations on this Form 483, mostly about quality system, production and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Zenara Pharma Private Limited?
Anitha P. Govada and Jose E. Melendez are named on this Form 483, for the inspection of Dec 16 – Dec 20, 2019. Each investigator has a profile showing what they cite most.
When was Zenara Pharma Private Limited inspected by FDA?
The inspection ran Dec 16 – Dec 20, 2019, and the Form 483 is dated December 20, 2019.
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.