Intas Pharmaceuticals Limited
Form 483 issued May 28, 2019 · Ahmedabad, India
- Inspection
- May 20 – May 28, 2019
- Investigator
- Patric C. Klotzbuecher
- Observations
- 7
- Pages
- 10
- FEI number
- 3004011473
In short: On May 28, 2019, FDA issued a Form 483 with 7 observations to Intas Pharmaceuticals Limited in Ahmedabad, Gujarat (FEI 3004011473) after an inspection that ran May 20 – May 28, 2019. The investigator was Patric C. Klotzbuecher. Most observations concern quality system and production.
At a glance
Quality system and production account for 6 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
Procedures describing the handling of written and oral complaints related to drug products are…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Written procedures are not established that describe the in-process controls to be conducted on appropriate samples…
- 04
Time limits are not established when appropriate for the completion of each production phase to assure…
This inspection in context
Patric C. Klotzbuecher
13 documents · 2014–2019
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmIntas Pharmaceuticals Limited history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Intas Pharmaceuticals Limited?
FDA listed 7 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Intas Pharmaceuticals Limited?
Patric C. Klotzbuecher is named on this Form 483, for the inspection of May 20 – May 28, 2019. Each investigator has a profile showing what they cite most.
When was Intas Pharmaceuticals Limited inspected by FDA?
The inspection ran May 20 – May 28, 2019, and the Form 483 is dated May 28, 2019.
How do I get the full Form 483 for Intas Pharmaceuticals 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.