B F Ascher & Co Inc
Form 483 issued July 15, 2015 · Lenexa, Kansas
- Inspection
- Jul 6 – Jul 15, 2015
- Investigator
- Ashley A. Mutawakkil
- Observations
- 10
- Pages
- 7
- FEI number
- 1911840
In short: On July 15, 2015, FDA issued a Form 483 with 10 observations to B F Ascher & Co Inc in Lenexa, Kansas (FEI 1911840) after an inspection that ran Jul 6 – Jul 15, 2015. The investigator was Ashley A. Mutawakkil. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
Laboratory controls and quality system account for 9 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
The quality control unit lacks responsibility to approve all procedures or specifications impacting on the identity…
- 03
Procedures describing the handling of written and oral complaints related to drug products are…
- 04
The written stability program for drug products does not include reliable, meaningful…
This inspection in context
Ashley A. Mutawakkil
4 documents · 2015–2022
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Kansas.
The firmB F Ascher & Co Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at B F Ascher & Co Inc?
FDA listed 10 observations on this Form 483, mostly about laboratory controls, quality system and packaging & labeling. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected B F Ascher & Co Inc?
Ashley A. Mutawakkil is named on this Form 483, for the inspection of Jul 6 – Jul 15, 2015. Each investigator has a profile showing what they cite most.
When was B F Ascher & Co Inc inspected by FDA?
The inspection ran Jul 6 – Jul 15, 2015, and the Form 483 is dated July 15, 2015.
How do I get the full Form 483 for B F Ascher & Co 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.