AIZANT DRUG RESEARCH SOLUTIONS PVT LTD
Form 483 issued January 24, 2020 · Hyderabad, India
- Inspection
- Jan 20 – Jan 24, 2020
- Investigator
- Liming Zhang
- Observations
- 7
- Pages
- 4
- FEI number
- 3008243902
In short: On January 24, 2020, FDA issued a Form 483 with 7 observations to AIZANT DRUG RESEARCH SOLUTIONS PVT LTD in Hyderabad, Telangana (FEI 3008243902) after an inspection that ran Jan 20 – Jan 24, 2020. The investigator was Liming Zhang. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and quality system 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
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
Washing and toilet facilities lack…
This inspection in context
Liming Zhang
19 documents · 2014–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmAIZANT DRUG RESEARCH SOLUTIONS PVT LTD history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AIZANT DRUG RESEARCH SOLUTIONS PVT LTD?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected AIZANT DRUG RESEARCH SOLUTIONS PVT LTD?
Liming Zhang is named on this Form 483, for the inspection of Jan 20 – Jan 24, 2020. Each investigator has a profile showing what they cite most.
When was AIZANT DRUG RESEARCH SOLUTIONS PVT LTD inspected by FDA?
The inspection ran Jan 20 – Jan 24, 2020, and the Form 483 is dated January 24, 2020.
How do I get the full Form 483 for AIZANT DRUG RESEARCH SOLUTIONS PVT LTD?
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.