International Trading Pharm Lab Inc
Form 483 issued April 29, 2016 · Paterson, New Jersey
- Inspection
- Apr 18 – Apr 29, 2016
- Investigators
- Helen Verdel· Niketa Patel
- Observations
- 3
- Pages
- 3
- FEI number
- 1000208853
In short: On April 29, 2016, FDA issued a Form 483 with 3 observations to International Trading Pharm Lab Inc in Paterson, New Jersey (FEI 1000208853) after an inspection that ran Apr 18 – Apr 29, 2016. The investigators were Helen Verdel and Niketa Patel. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
3 of 3 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
The suitability of all testing methods is not verified under…
- 02
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 03
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are…
This inspection in context
Helen Verdel
13 documents · 2015–2023
Cites 211.67 (equipment cleaning and maintenance) 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 211.194(a)(2)
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 3 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected International Trading Pharm Lab Inc?
Helen Verdel and Niketa Patel are named on this Form 483, for the inspection of Apr 18 – Apr 29, 2016. Each investigator has a profile showing what they cite most.
When was International Trading Pharm Lab Inc inspected by FDA?
The inspection ran Apr 18 – Apr 29, 2016, and the Form 483 is dated April 29, 2016.
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.