Intas Pharmaceuticals Ltd.
Form 483 issued August 9, 2022 · Ahmedabad, India
- Inspection
- Aug 1 – Aug 9, 2022
- Investigators
- Arsen Karapetyan· Massod Rahimi· Michael R. Shanks
- Observations
- 9
- Pages
- 11
- FEI number
- 3007277149
In short: On August 9, 2022, FDA issued a Form 483 with 9 observations to Intas Pharmaceuticals Ltd. in Ahmedabad, Gujarat (FEI 3007277149) after an inspection that ran Aug 1 – Aug 9, 2022. The investigators were Arsen Karapetyan, Massod Rahimi, Michael R. Shanks and Zhong Li. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Facilities & equipment and quality system account for 6 of 9 observations.
Most cited: 21 CFR 211.113 (2×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm’s quality unit’s oversight of your GMP…
- 02
Aseptic technique in the drug substance and drug product…
- 03
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions and personnel…
- 04
Your firm lacks an established cleaning and sanitization program to prevent the introduction of microbial J…
This inspection in context
Arsen Karapetyan
43 documents · 2014–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
The firmIntas Pharmaceuticals Ltd. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Intas Pharmaceuticals Ltd.?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Intas Pharmaceuticals Ltd.?
Arsen Karapetyan, Massod Rahimi, Michael R. Shanks and Zhong Li are named on this Form 483, for the inspection of Aug 1 – Aug 9, 2022. Each investigator has a profile showing what they cite most.
When was Intas Pharmaceuticals Ltd. inspected by FDA?
The inspection ran Aug 1 – Aug 9, 2022, and the Form 483 is dated August 9, 2022.
How do I get the full Form 483 for Intas Pharmaceuticals 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.