Pharmaceutics International, Inc.
Form 483 issued October 30, 2020 · Cockeysville, Maryland
- Inspection
- Oct 19 – Oct 30, 2020
- Investigators
- Junho Pak· Yvins Dezan
- Observations
- 5
- Pages
- 10
- FEI number
- 3006503102
In short: On October 30, 2020, FDA issued a Form 483 with 5 observations to Pharmaceutics International, Inc. in Cockeysville, Maryland (FEI 3006503102) after an inspection that ran Oct 19 – Oct 30, 2020. The investigators were Junho Pak and Yvins Dezan. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Time limits are not established when appropriate for the completion of each production phase to assure…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
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 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmaceutics International, Inc.?
FDA listed 5 observations on this Form 483, mostly about production, facilities & equipment and quality system. 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.