Indoco Remedies Limited
Form 483 issued February 28, 2023 · Verna, India
- Inspection
- Feb 20 – Feb 28, 2023
- Investigators
- Anastasia M. Shields· Jeffrey P. Raimondi
- Observations
- 4
- Pages
- 5
- FEI number
- 3005124189
In short: On February 28, 2023, FDA issued a Form 483 with 4 observations to Indoco Remedies Limited in Verna, Goa (FEI 3005124189) after an inspection that ran Feb 20 – Feb 28, 2023. The investigators were Anastasia M. Shields and Jeffrey P. Raimondi. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 04
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic…
This inspection in context
Anastasia M. Shields
45 documents · 2016–2026
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 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
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 facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Indoco Remedies Limited?
Anastasia M. Shields and Jeffrey P. Raimondi are named on this Form 483, for the inspection of Feb 20 – Feb 28, 2023. Each investigator has a profile showing what they cite most.
When was Indoco Remedies Limited inspected by FDA?
The inspection ran Feb 20 – Feb 28, 2023, and the Form 483 is dated February 28, 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.