Aspen Biopharma Labs Pvt Ltd
FDA inspection history across 2 sites, 2024 to 2025
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2024: one Form 483; 2025: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2024–25One Form 483 and one warning letter, at Medchal Malkajgiri, India and Hyderabad, India.
Cited most
Across all Aspen Biopharma Labs Pvt observations on file
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.166Stability testing2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.170Reserve samples1
The complete Aspen Biopharma Labs Pvt file.
All 2 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
Hyderabad, India
One warning letter · 2025
Latest: Warning letter, Mar 5, 2025 →Medchal Malkajgiri, India
One Form 483 · 2024 · 9 observations
Latest: Form 483, Sep 21, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-03-05 | Warning letter Warning letter | Hyderabad, India | — | $99 |
| 2024-09-21 | 483 Form 483 | Medchal Malkajgiri, India | 9 | $99 |
FEI number 3012796281 · most recent document Mar 5, 2025
About Aspen Biopharma Labs Pvt Ltd
How many FDA Form 483s has Aspen Biopharma Labs Pvt Ltd received?
FDA Intel has 1 Form 483 on file for Aspen Biopharma Labs Pvt Ltd; the most recent is dated Sep 21, 2024.
When was Aspen Biopharma Labs Pvt Ltd last inspected by FDA?
The most recent FDA inspection document on file for Aspen Biopharma Labs Pvt Ltd is a Form 483 dated Sep 21, 2024, for the site in Medchal Malkajgiri, India.
What did FDA cite at Aspen Biopharma Labs Pvt Ltd?
The regulations cited most in the observations on file for Aspen Biopharma Labs Pvt Ltd are 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.166 (Stability testing), 2 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time.
Has Aspen Biopharma Labs Pvt Ltd received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Aspen Biopharma Labs Pvt Ltd; the most recent is dated Mar 5, 2025.