In short: On March 28, 2025, FDA issued a Form 483 with 4 observations to an FDA-inspected site. The investigator was Nicholas L. Hunt. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Production and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Quality unit oversight for manufacturing and release…
- 02
Environmental controls designed to minimize contamination risk are deficient for API manufactured by hat…
- 03
Water used in the steps during processing of nonsterile API that is intended for use to…
- 04
Instructions and documentation in executed batch production records were not always clear and deviations…
This inspection in context
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 4 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Nicholas L. Hunt is named on this Form 483. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
This Form 483 is dated March 28, 2025.
How do I get the full Form 483 for an FDA-inspected site?
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.