Advance Pharmaceutical In a
Form 483 issued December 2, 2015 · Holtsville, New York
- Inspection
- Nov 12 – Dec 2, 2015
- Investigators
- Clarisse K. Green· Robert A. Mier
- Observations
- 11
- Pages
- 7
- FEI number
- 2434807
In short: On December 2, 2015, FDA issued a Form 483 with 11 observations to Advance Pharmaceutical In a in Holtsville, New York (FEI 2434807) after an inspection that ran Nov 12 – Dec 2, 2015. The investigators were Clarisse K. Green and Robert A. Mier. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Quality system and production account for 7 of 11 observations.
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 02
The written stability testing…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Clarisse K. Green
1 document · 2015
Cites 211.100(a) (written procedures; deviations) 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 211.110(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Advance Pharmaceutical In a?
FDA listed 11 observations on this Form 483, mostly about quality system, production and laboratory controls. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Advance Pharmaceutical In a?
Clarisse K. Green and Robert A. Mier are named on this Form 483, for the inspection of Nov 12 – Dec 2, 2015. Each investigator has a profile showing what they cite most.
When was Advance Pharmaceutical In a inspected by FDA?
The inspection ran Nov 12 – Dec 2, 2015, and the Form 483 is dated December 2, 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.