Annora Pharma Private Limited
Form 483 issued January 20, 2023 · Sangareddy, India
- Inspection
- Jan 16 – Jan 20, 2023
- Investigator
- Saied A. Asbagh
- Observations
- 1
- Pages
- 2
- FEI number
- 3013944676
In short: On January 20, 2023, FDA issued a Form 483 with 1 observation to Annora Pharma Private Limited in Sangareddy, Telangana (FEI 3013944676) after an inspection that ran Jan 16 – Jan 20, 2023. The investigator was Saied A. Asbagh. Most observations concern quality system; the most-cited regulation is 21 CFR 211.25 (personnel qualifications).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.25 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Employees are not given training in the particular operations they perform as part of their function…
This inspection in context
Saied A. Asbagh
12 documents · 2016–2024
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in California.
The firmAnnora Pharma Private Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.25
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Annora Pharma Private Limited?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.25 (personnel qualifications). The opening words of each observation are shown on this page.
Who inspected Annora Pharma Private Limited?
Saied A. Asbagh is named on this Form 483, for the inspection of Jan 16 – Jan 20, 2023. Each investigator has a profile showing what they cite most.
When was Annora 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 Annora 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.