Indoco Remedies Limited
Form 483 issued September 4, 2016
- Inspection
- Aug 31 – Sep 4, 2016
- Investigator
- Nicholas Violand
- Observations
- 6
- Pages
- 5
- FEI number
- 3005124189
In short: On September 4, 2016, FDA issued a Form 483 with 6 observations to Indoco Remedies Limited (FEI 3005124189) after an inspection that ran Aug 31 – Sep 4, 2016. The investigator was Nicholas Violand. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and production account for 4 of 6 observations.
Most cited: 21 CFR 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations of an unexplained discrepancy and a failure of a batch or any of its components…
- 02
The quality control unit lacks the responsibility and authority to approve and…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
This inspection in context
Nicholas Violand
17 documents · 2013–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in New Jersey.
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 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Indoco Remedies Limited?
FDA listed 6 observations on this Form 483, mostly about quality system, production and facilities & equipment. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Indoco Remedies Limited?
Nicholas Violand is named on this Form 483, for the inspection of Aug 31 – Sep 4, 2016. Each investigator has a profile showing what they cite most.
When was Indoco Remedies Limited inspected by FDA?
The inspection ran Aug 31 – Sep 4, 2016, and the Form 483 is dated September 4, 2016.
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.