Indoco Remedies Limited
FDA inspection history across 4 sites, 2016 to 2024
- 5
- Form 483s
- 2
- Warning letters
Every document, by year
- Warning letter
- Form 483
2016: one Form 483; 2017: one warning letter; 2018: one Form 483; 2019: one Form 483; 2023: one Form 483; 2024: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–19Three Form 483s and one warning letter, at Verna, India and Vasco Da Gama, India.
- 2023–24Two Form 483s and one warning letter, at Verna, India; Mumbai, India and Vasco Da Gama, Goa, India.
- 2024The longest 483 on file: 7 observations over 13 pages at Vasco Da Gama, Goa, India.
Cited most
Across all Indoco Remedies Limited observations on file
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.22Responsibilities of quality control unit4
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.192Production record review2
- 21 CFR 211.198Complaint files2
The complete Indoco Remedies Limited file.
All 7 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Verna, India
Two Form 483s · 2018 to 2023 · 6 observations
Latest: Form 483, Feb 28, 2023 →Mumbai, India
One warning letter · 2024
Latest: Warning letter, Dec 16, 2024 →Vasco Da Gama, Goa, India
One Form 483 · 2024 · 7 observations
Latest: Form 483, Jul 26, 2024 →Vasco Da Gama, India
One Form 483 · 2019 · 2 observations
Latest: Form 483, Jun 4, 2019 →
Also: two documents not tied to a site.
Documents
7 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-12-16 | Warning letter Warning letter | Mumbai, India | — | $99 |
| 2024-07-26 | 483 Form 483 | Vasco Da Gama, Goa, India | 7 | $99 |
| 2023-02-28 | 483 Form 483 | Verna, India | 4 | $99 |
| 2019-06-04 | 483 Form 483 | Vasco Da Gama, India | 2 | $99 |
| 2018-11-21 | 483 Form 483 | Verna, India | 2 | $99 |
| 2017-03-27 | Warning letter Warning letter | — | — | $99 |
| 2016-09-04 | 483 Form 483 | — | 6 | $99 |
Investigators on these documents
Anastasia M. Shields (1)Jeffrey P. Raimondi (1)Jose A. Cruz-Gonzalez (1)Nicholas Violand (1)Saleem A. Akhtar (1)Wayne D. McGrath (1)
FEI number 3005124189 · most recent document Dec 16, 2024
About Indoco Remedies Limited
How many FDA Form 483s has Indoco Remedies Limited received?
FDA Intel has 5 Form 483s on file for Indoco Remedies Limited; the most recent is dated Jul 26, 2024.
When was Indoco Remedies Limited last inspected by FDA?
The most recent FDA inspection document on file for Indoco Remedies Limited is a Form 483 dated Jul 26, 2024, for the site in Vasco Da Gama, Goa, India.
What did FDA cite at Indoco Remedies Limited?
The regulations cited most in the observations on file for Indoco Remedies Limited are 21 CFR 211.113 (Control of microbiological contamination), 4 times; 21 CFR 211.22 (Responsibilities of quality control unit), 4 times; 21 CFR 211.42 (Design and construction features), 3 times.
Has Indoco Remedies Limited received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Indoco Remedies Limited; the most recent is dated Dec 16, 2024.