Advance Pharmaceutical In a
Form 483 issued March 6, 2015 · Holtsville, New York
- Inspection
- Feb 25 – Mar 6, 2015
- Investigators
- Demitria J. Xiradakis· Samina S. Khan
- Observations
- 5
- Pages
- 4
- FEI number
- 2434807
In short: On March 6, 2015, FDA issued a Form 483 with 5 observations to Advance Pharmaceutical In a in Holtsville, New York (FEI 2434807) after an inspection that ran Feb 25 – Mar 6, 2015. The investigators were Demitria J. Xiradakis and Samina S. Khan. Most observations concern production and quality system.
At a glance
Production and quality system account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Deviations from written production and process control…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods…
- 04
Control procedures are not established which monitor the output of those manufacturing processes that may be…
This inspection in context
Demitria J. Xiradakis
3 documents · 2015–2016
Cites 211.110 (sampling and testing of in-process materials and drug products) more than any other section. Most of their documents are for sites in New York.
The firmAdvance Pharmaceutical In a history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Advance Pharmaceutical In a?
FDA listed 5 observations on this Form 483, mostly about production, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Advance Pharmaceutical In a?
Demitria J. Xiradakis and Samina S. Khan are named on this Form 483, for the inspection of Feb 25 – Mar 6, 2015. Each investigator has a profile showing what they cite most.
When was Advance Pharmaceutical In a inspected by FDA?
The inspection ran Feb 25 – Mar 6, 2015, and the Form 483 is dated March 6, 2015.
How do I get the full Form 483 for Advance Pharmaceutical In a?
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.