International Trading Pharm Lab Inc
Form 483 issued October 29, 2019 · Paterson, New Jersey
- Inspection
- Oct 15 – Oct 29, 2019
- Investigator
- Niketa Patel
- Observations
- 6
- Pages
- 6
- FEI number
- 1000208853
In short: On October 29, 2019, FDA issued a Form 483 with 6 observations to International Trading Pharm Lab Inc in Paterson, New Jersey (FEI 1000208853) after an inspection that ran Oct 15 – Oct 29, 2019. The investigator was Niketa Patel. Most observations concern quality system and facilities & equipment.
At a glance
4 of 6 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
The responsibilities and procedures applicable to the quality control unit are not fully followed. Specially, The…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
The suitability of all testing methods is not verified under…
This inspection in context
Niketa Patel
15 documents · 2016–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
The firmInternational Trading Pharm Lab Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at International Trading Pharm Lab Inc?
FDA listed 6 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected International Trading Pharm Lab Inc?
Niketa Patel is named on this Form 483, for the inspection of Oct 15 – Oct 29, 2019. Each investigator has a profile showing what they cite most.
When was International Trading Pharm Lab Inc inspected by FDA?
The inspection ran Oct 15 – Oct 29, 2019, and the Form 483 is dated October 29, 2019.
How do I get the full Form 483 for International Trading Pharm Lab Inc?
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.