Galephar Pharmaceutical Research Inc.
FDA inspection history in Juncos, Puerto Rico, 2021 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2021: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021One Form 483, at Juncos, Puerto Rico.
- 2021The longest 483 on file: 2 observations over 4 pages at Juncos, Puerto Rico.
- 2024One Form 483, at Juncos, Puerto Rico.
Cited most
Across all Galephar Pharmaceutical Research observations on file
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.166Stability testing1
- 21 CFR 211.188(b)(12)Batch production and control records1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Galephar Pharmaceutical Research 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
Juncos, Puerto Rico
Two Form 483s · 2021 to 2024 · 3 observations
Latest: Form 483, Oct 18, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-10-18 | 483 Form 483 | Juncos, Puerto Rico | 1 | $99 |
| 2021-06-09 | 483 Form 483 | Juncos, Puerto Rico | 2 | $99 |
Investigators on these documents
FEI number 3003068480 · most recent document Oct 18, 2024
About Galephar Pharmaceutical Research Inc.
How many FDA Form 483s has Galephar Pharmaceutical Research Inc. received?
FDA Intel has 2 Form 483s on file for Galephar Pharmaceutical Research Inc.; the most recent is dated Oct 18, 2024.
When was Galephar Pharmaceutical Research Inc. last inspected by FDA?
The most recent FDA inspection document on file for Galephar Pharmaceutical Research Inc. is a Form 483 dated Oct 18, 2024, for the site in Juncos, Puerto Rico.
What did FDA cite at Galephar Pharmaceutical Research Inc.?
The regulations cited most in the observations on file for Galephar Pharmaceutical Research Inc. are 21 CFR 211.165 (Testing and release for distribution), 1 time; 21 CFR 211.166 (Stability testing), 1 time; 21 CFR 211.188(b)(12) (Batch production and control records), 1 time.