Indoco Remedies Limited
Form 483 issued January 25, 2019 · Vasco Da Gama, India
- Inspection
- Jan 17 – Jan 25, 2019
- Investigators
- Justin A. Boyd· Rumany C. Penn
- Observations
- 1
- Pages
- 7
- FEI number
- 3006644152
In short: On January 25, 2019, FDA issued a Form 483 with 1 observation to Indoco Remedies Limited in Vasco Da Gama, India (FEI 3006644152) after an inspection that ran Jan 17 – Jan 25, 2019. The investigators were Justin A. Boyd and Rumany C. Penn. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 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
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Justin A. Boyd
61 documents · 2010–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmIndoco Remedies 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Indoco Remedies Limited?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Indoco Remedies Limited?
Justin A. Boyd and Rumany C. Penn are named on this Form 483, for the inspection of Jan 17 – Jan 25, 2019. Each investigator has a profile showing what they cite most.
When was Indoco Remedies Limited inspected by FDA?
The inspection ran Jan 17 – Jan 25, 2019, and the Form 483 is dated January 25, 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.