Pharmaceutics International Inc
Form 483 issued November 14, 2022 · Hunt Valley, Maryland
- Inspection
- May 10 – Nov 14, 2022
- Observations
- 3
- Pages
- 4
- FEI number
- 1000513101
In short: On November 14, 2022, FDA issued a Form 483 with 3 observations to Pharmaceutics International Inc in Hunt Valley, Maryland (FEI 1000513101) after an inspection that ran May 10 – Nov 14, 2022. Most observations concern facilities & equipment and materials.
At a glance
Facilities & equipment and materials account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
- 02
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 03
The written stability program for drug products does not describe the storage conditions for…
This inspection in context
Questions about this 483
What did FDA find at Pharmaceutics International Inc?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment, materials and laboratory controls. The opening words of each observation are shown on this page.
When was Pharmaceutics International Inc inspected by FDA?
The inspection ran May 10 – Nov 14, 2022, and the Form 483 is dated November 14, 2022.
How do I get the full Form 483 for Pharmaceutics International 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.