Indoco Remedies Limited
Form 483 issued January 20, 2023 · Verna, India
- Inspection
- Jan 16 – Jan 20, 2023
- Investigators
- Kellia N. Hicks· Sandra A. Boyd
- Observations
- 9
- Pages
- 12
- FEI number
- 3006644152
In short: On January 20, 2023, FDA issued a Form 483 with 9 observations to Indoco Remedies Limited in Verna, Goa (FEI 3006644152) after an inspection that ran Jan 16 – Jan 20, 2023. The investigators were Kellia N. Hicks and Sandra A. Boyd. Most observations concern quality system and facilities & equipment.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review whether or not the batch has…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in taster…
- 03
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 04
The responsibilities and procedures applicable to the quality control unit are not in…
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 9 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Indoco Remedies Limited?
Kellia N. Hicks and Sandra A. Boyd are named on this Form 483, for the inspection of Jan 16 – Jan 20, 2023. Each investigator has a profile showing what they cite most.
When was Indoco Remedies Limited inspected by FDA?
The inspection ran Jan 16 – Jan 20, 2023, and the Form 483 is dated January 20, 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.