Indoco Remedies Limited
FDA inspection history across 3 sites, 2018 to 2023
- 4
- Form 483s
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
2018: one Form 483; 2019: one close-out letter and one Form 483; 2023: two Form 483s.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–19Two Form 483s and one close-out letter, at Vasco Da Gama, India and Mumbai, India.
- 2023Two Form 483s, at Verna, India.
- 2023The longest 483 on file: 9 observations over 12 pages at Verna, India.
Cited most
Across all Indoco Remedies Limited observations on file
- 21 CFR 211.192Production record review4
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.113(a)Control of microbiological contamination1
The complete Indoco Remedies Limited file.
All 5 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 · 2023 · 13 observations
Latest: Form 483, Oct 18, 2023 →Vasco Da Gama, India
Two Form 483s · 2018 to 2019 · 2 observations
Latest: Form 483, Jan 25, 2019 →Mumbai, India
One close-out letter · 2019
Latest: Close-out, Jul 16, 2019 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-10-18 | 483 Form 483 | Verna, India | 4 | $99 |
| 2023-01-20 | 483 Form 483 | Verna, India | 9 | $99 |
| 2019-07-16 | Close-out Close-out letter | Mumbai, India | — | $99 |
| 2019-01-25 | 483 Form 483 | Vasco Da Gama, India | 1 | $99 |
| 2018-01-19 | 483 Form 483 | Vasco Da Gama, India | 1 | $99 |
Investigators on these documents
Kellia N. Hicks (2)Cheryl Clausen (1)Justin A. Boyd (1)Rumany C. Penn (1)Sandra A. Boyd (1)
FEI number 3006644152 · most recent document Oct 18, 2023
About Indoco Remedies Limited
How many FDA Form 483s has Indoco Remedies Limited received?
FDA Intel has 4 Form 483s on file for Indoco Remedies Limited; the most recent is dated Oct 18, 2023.
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 Oct 18, 2023, for the site in Verna, 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 211.192 (Production record review), 4 times; 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.22 (Responsibilities of quality control unit), 2 times.