Indoco Remedies Limited
Form 483 issued July 26, 2024 · Vasco Da Gama, Goa, India
- Inspection
- Jul 16 – Jul 26, 2024
- Investigators
- Saleem A. Akhtar· Wayne D. McGrath
- Observations
- 7
- Pages
- 13
- FEI number
- 3005124189
In short: On July 26, 2024, FDA issued a Form 483 with 7 observations to Indoco Remedies Limited in Vasco Da Gama, Goa, Goa (FEI 3005124189) after an inspection that ran Jul 16 – Jul 26, 2024. The investigators were Saleem A. Akhtar and Wayne D. McGrath. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 5 of 7 observations.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedmes describing the handling of written and oral complaints related to diug products are…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
This inspection in context
Saleem A. Akhtar
35 documents · 2004–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Indoco Remedies Limited?
FDA listed 7 observations on this Form 483, mostly about production, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Indoco Remedies Limited?
Saleem A. Akhtar and Wayne D. McGrath are named on this Form 483, for the inspection of Jul 16 – Jul 26, 2024. Each investigator has a profile showing what they cite most.
When was Indoco Remedies Limited inspected by FDA?
The inspection ran Jul 16 – Jul 26, 2024, and the Form 483 is dated July 26, 2024.
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.