Intas Pharmaceuticals Ltd.
Form 483 issued May 10, 2017 · Ahmedabad, India
- Inspection
- Apr 26 – May 10, 2017
- Investigators
- Bijoy Panicker· Daniel J. Roberts· Patric C. Klotzbuecher
- Observations
- 14
- Pages
- 16
- FEI number
- 3007277149
In short: On May 10, 2017, FDA issued a Form 483 with 14 observations to Intas Pharmaceuticals Ltd. in Ahmedabad, Gujarat (FEI 3007277149) after an inspection that ran Apr 26 – May 10, 2017. The investigators were Bijoy Panicker, Daniel J. Roberts and Patric C. Klotzbuecher. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Observations span 4 systems, led by laboratory controls.
Most cited: 21 CFR 211.194 (2×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory records are deficient in that they do not include a complete record of all…
- 02
Appropriate controls are not exercised over computers or related systems, There was a failure to maintain…
- 03
The control records are deficient in that they are not an accurate reproduction of the appropriate…
- 04
Laboratory records do not include the initials or signature of a second person showing that the…
This inspection in context
Bijoy Panicker
34 documents · 2017–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
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 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Intas Pharmaceuticals Ltd.?
FDA listed 14 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Intas Pharmaceuticals Ltd.?
Bijoy Panicker, Daniel J. Roberts and Patric C. Klotzbuecher are named on this Form 483, for the inspection of Apr 26 – May 10, 2017. Each investigator has a profile showing what they cite most.
When was Intas Pharmaceuticals Ltd. inspected by FDA?
The inspection ran Apr 26 – May 10, 2017, and the Form 483 is dated May 10, 2017.
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.