Indoco Remedies Limited
Form 483 issued June 4, 2019 · Vasco Da Gama, India
- Inspection
- May 27 – Jun 4, 2019
- Investigator
- Jose A. Cruz-Gonzalez
- Observations
- 2
- Pages
- 4
- FEI number
- 3005124189
In short: On June 4, 2019, FDA issued a Form 483 with 2 observations to Indoco Remedies Limited in Vasco Da Gama, India (FEI 3005124189) after an inspection that ran May 27 – Jun 4, 2019. The investigator was Jose A. Cruz-Gonzalez. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
Laboratory controls and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.166 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Determinations of conformance to appropriate written specifications for acceptance are…
- 02
Investigations of a failure of a batch or any of its components to meet any of…
This inspection in context
Jose A. Cruz-Gonzalez
11 documents · 2013–2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmIndoco Remedies Limited history
All 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Indoco Remedies Limited?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected Indoco Remedies Limited?
Jose A. Cruz-Gonzalez is named on this Form 483, for the inspection of May 27 – Jun 4, 2019. Each investigator has a profile showing what they cite most.
When was Indoco Remedies Limited inspected by FDA?
The inspection ran May 27 – Jun 4, 2019, and the Form 483 is dated June 4, 2019.
How do I get the full Form 483 for Indoco Remedies 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.