Pharmaceutics International Inc
Form 483 issued May 22, 2015 · Hunt Valley, Maryland
- Inspection
- May 11 – May 22, 2015
- Investigators
- James Michael Simpson· Toyin B. Oladimeji
- Observations
- 3
- Pages
- 3
- FEI number
- 1000513101
In short: On May 22, 2015, FDA issued a Form 483 with 3 observations to Pharmaceutics International Inc in Hunt Valley, Maryland (FEI 1000513101) after an inspection that ran May 11 – May 22, 2015. The investigators were James Michael Simpson and Toyin B. Oladimeji. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment 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
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
James Michael Simpson
7 documents · 2015–2018
Cites 820.30(c) (design controls) more than any other section. Most of their documents are for sites in Virginia.
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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmaceutics International Inc?
FDA listed 3 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?
James Michael Simpson and Toyin B. Oladimeji are named on this Form 483, for the inspection of May 11 – May 22, 2015. Each investigator has a profile showing what they cite most.
When was Pharmaceutics International Inc inspected by FDA?
The inspection ran May 11 – May 22, 2015, and the Form 483 is dated May 22, 2015.
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.