Macleods Pharmaceuticals Limited
FDA inspection history in Solan, India, 2021 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2021: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021–23Two Form 483s, at Solan, India.
- 2023The longest 483 on file: 8 observations over 4 pages at Solan, India.
Cited most
Across all Macleods Pharmaceuticals Limited observations on file
- 21 CFR 211.192Production record review3
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.110Sampling and testing of in-process materials and drug products2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
- 21 CFR 211.113(a)Control of microbiological contamination1
The complete Macleods Pharmaceuticals Limited 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
Solan, India
Two Form 483s · 2021 to 2023 · 15 observations
Latest: Form 483, Oct 20, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-10-20 | 483 Form 483 | Solan, India | 8 | $99 |
| 2021-11-01 | 483 Form 483 | Solan, India | 7 | $99 |
Investigators on these documents
FEI number 3007517881 · most recent document Oct 20, 2023
About Macleods Pharmaceuticals Limited
How many FDA Form 483s has Macleods Pharmaceuticals Limited received?
FDA Intel has 2 Form 483s on file for Macleods Pharmaceuticals Limited; the most recent is dated Oct 20, 2023.
When was Macleods Pharmaceuticals Limited last inspected by FDA?
The most recent FDA inspection document on file for Macleods Pharmaceuticals Limited is a Form 483 dated Oct 20, 2023, for the site in Solan, India.
What did FDA cite at Macleods Pharmaceuticals Limited?
The regulations cited most in the observations on file for Macleods Pharmaceuticals Limited are 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 3 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 2 times.