Galephar Pharmaceutical Research Inc.
Form 483 issued January 20, 2023 · Humacao, Puerto Rico
- Inspection
- Jan 11 – Jan 20, 2023
- Investigator
- Alan A. Rivera
- Observations
- 2
- Pages
- 4
- FEI number
- 3008206797
In short: On January 20, 2023, FDA issued a Form 483 with 2 observations to Galephar Pharmaceutical Research Inc. in Humacao, Puerto Rico (FEI 3008206797) after an inspection that ran Jan 11 – Jan 20, 2023. The investigator was Alan A. Rivera. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination that would…
This inspection in context
Alan A. Rivera
16 documents · 2022–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmGalephar Pharmaceutical Research Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Galephar Pharmaceutical Research Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Galephar Pharmaceutical Research Inc.?
Alan A. Rivera is named on this Form 483, for the inspection of Jan 11 – Jan 20, 2023. Each investigator has a profile showing what they cite most.
When was Galephar Pharmaceutical Research Inc. inspected by FDA?
The inspection ran Jan 11 – Jan 20, 2023, and the Form 483 is dated January 20, 2023.
How do I get the full Form 483 for Galephar Pharmaceutical Research Inc.?
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