Indoco Remedies Limited
Form 483 issued October 18, 2023 · Verna, India
- Inspection
- Oct 12 – Oct 18, 2023
- Investigator
- Kellia N. Hicks
- Observations
- 4
- Pages
- 6
- FEI number
- 3006644152
In short: On October 18, 2023, FDA issued a Form 483 with 4 observations to Indoco Remedies Limited in Verna, Goa (FEI 3006644152) after an inspection that ran Oct 12 – Oct 18, 2023. The investigator was Kellia N. Hicks. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 3 of 4 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination…
- 02
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Kellia N. Hicks
28 documents · 2017–2025
Cites 211.192 (production record review) 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 4 observations on this Form 483, mostly about quality system, facilities & equipment and production. 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?
Kellia N. Hicks is named on this Form 483, for the inspection of Oct 12 – Oct 18, 2023. Each investigator has a profile showing what they cite most.
When was Indoco Remedies Limited inspected by FDA?
The inspection ran Oct 12 – Oct 18, 2023, and the Form 483 is dated October 18, 2023.
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.