Pharmaceutics International Inc
Form 483 issued October 30, 2020 · Hunt Valley, Maryland
- Inspection
- Oct 19 – Oct 30, 2020
- Investigators
- Junho Pak· Yvins Dezan
- Observations
- 4
- Pages
- 8
- FEI number
- 1000513101
In short: On October 30, 2020, FDA issued a Form 483 with 4 observations to Pharmaceutics International Inc in Hunt Valley, Maryland (FEI 1000513101) after an inspection that ran Oct 19 – Oct 30, 2020. The investigators were Junho Pak and Yvins Dezan. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 4 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
Employees are not given training in the particular operations they perform as part of their function…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Buildings used in the holding of a drug product are not maintained in a…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Junho Pak
28 documents · 2012–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmPharmaceutics International Inc history
All 11 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.25
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmaceutics International Inc?
FDA listed 4 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Pharmaceutics International Inc?
Junho Pak and Yvins Dezan are named on this Form 483, for the inspection of Oct 19 – Oct 30, 2020. Each investigator has a profile showing what they cite most.
When was Pharmaceutics International Inc inspected by FDA?
The inspection ran Oct 19 – Oct 30, 2020, and the Form 483 is dated October 30, 2020.
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.