Galephar Pharmaceutical Research Inc.
Form 483 issued October 18, 2024 · Juncos, Puerto Rico
- Inspection
- Oct 18, 2024
- Observations
- 1
- Pages
- 3
- FEI number
- 3003068480
In short: On October 18, 2024, FDA issued a Form 483 with 1 observation to Galephar Pharmaceutical Research Inc. in Juncos, Puerto Rico (FEI 3003068480) after an inspection that ran Oct 18, 2024. Most observations concern production; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.188(b)(12) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Batch production and control records do not include the results of any investigation made into any…
This inspection in context
Questions about this 483
What did FDA find at Galephar Pharmaceutical Research Inc.?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
When was Galephar Pharmaceutical Research Inc. inspected by FDA?
The inspection ran Oct 18, 2024, and the Form 483 is dated October 18, 2024.
How do I get the full Form 483 for Galephar Pharmaceutical Research Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.