Yash Pharma Laboratories Pvt Ltd.
FDA inspection history in Roorkee, India, 2019 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Roorkee, India.
- 2019The longest 483 on file: 8 observations over 8 pages at Roorkee, India.
- 2024One Form 483, at Roorkee, India.
Cited most
Across all Yash Pharma Laboratories Pvt observations on file
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.122Materials examination and usage criteria1
- 21 CFR 211.132Tamper-evident packaging requirements for over-the-counter (OTC) human drug products1
The complete Yash Pharma Laboratories 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
Roorkee, India
Two Form 483s · 2019 to 2024 · 10 observations
Latest: Form 483, Dec 6, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-12-06 | 483 Form 483 | Roorkee, India | 2 | $99 |
| 2019-09-03 | 483 Form 483 | Roorkee, India | 8 | $99 |
Investigators on these documents
Letitia Robinson (1)Rajiv R. Srivastava (1)Truong X. Nguyen (1)
FEI number 3012020703 · most recent document Dec 6, 2024
About Yash Pharma Laboratories Pvt Ltd.
How many FDA Form 483s has Yash Pharma Laboratories Pvt Ltd. received?
FDA Intel has 2 Form 483s on file for Yash Pharma Laboratories Pvt Ltd.; the most recent is dated Dec 6, 2024.
When was Yash Pharma Laboratories Pvt Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Yash Pharma Laboratories Pvt Ltd. is a Form 483 dated Dec 6, 2024, for the site in Roorkee, India.
What did FDA cite at Yash Pharma Laboratories Pvt Ltd.?
The regulations cited most in the observations on file for Yash Pharma Laboratories Pvt Ltd. are 21 CFR 211.22 (Responsibilities of quality control unit), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time.