Micro Labs Limited
FDA inspection history in Verna, India, 2015 to 2025
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2015: one warning letter; 2024: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One warning letter, at Verna, India.
- 2024–25Two Form 483s, at Verna, India.
- 2024The longest 483 on file: 6 observations over 25 pages at Verna, India.
Cited most
Across all Micro Labs Limited observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.160General requirements1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.25Personnel qualifications1
The complete Micro Labs Limited file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Verna, India
Two Form 483s and one warning letter · 2015 to 2025 · 8 observations
Latest: Form 483, May 30, 2025 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-05-30 | 483 Form 483 | Verna, India | 2 | $99 |
| 2024-02-09 | 483 Form 483 | Verna, India | 6 | $99 |
| 2015-01-09 | Warning letter Warning letter | Verna, India | — | $99 |
Investigators on these documents
Lauren N. Howard (1)Patty P. Kaewussdangkul (1)Pratik S. Upadhyay (1)
FEI number 3005210225 · most recent document May 30, 2025
About Micro Labs Limited
How many FDA Form 483s has Micro Labs Limited received?
FDA Intel has 2 Form 483s on file for Micro Labs Limited; the most recent is dated May 30, 2025.
When was Micro Labs Limited last inspected by FDA?
The most recent FDA inspection document on file for Micro Labs Limited is a Form 483 dated May 30, 2025, for the site in Verna, India.
What did FDA cite at Micro Labs Limited?
The regulations cited most in the observations on file for Micro Labs Limited are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.160 (General requirements), 1 time.
Has Micro Labs Limited received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Micro Labs Limited; the most recent is dated Jan 9, 2015.