Algunas Inc. dba Woodland Hills Compounding Pharmacy
Form 483 issued April 29, 2016 · Woodl and Hill s, California
- Inspection
- Apr 29, 2016
- Investigator
- Roger F. Zabinski
- Observations
- 3
- Pages
- 2
- FEI number
- 3011830726
In short: On April 29, 2016, FDA issued a Form 483 with 3 observations to Algunas Inc. dba Woodland Hills Compounding Pharmacy in Woodl and Hill s, California (FEI 3011830726) after an inspection that ran Apr 29, 2016. The investigator was Roger F. Zabinski. Most observations concern quality system and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
Procedures describing the handling of written and oral complaints related to drug products are…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Routine calibration of electronic equipment is not performed according to a written program designed to assure…
This inspection in context
Roger F. Zabinski
36 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmAlgunas Inc. dba Woodland Hills Compounding Pharmacy history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Algunas Inc. dba Woodland Hills Compounding Pharmacy?
FDA listed 3 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Algunas Inc. dba Woodland Hills Compounding Pharmacy?
Roger F. Zabinski is named on this Form 483, for the inspection of Apr 29, 2016. Each investigator has a profile showing what they cite most.
When was Algunas Inc. dba Woodland Hills Compounding Pharmacy inspected by FDA?
The inspection ran Apr 29, 2016, and the Form 483 is dated April 29, 2016.
How do I get the full Form 483 for Algunas Inc. dba Woodland Hills Compounding Pharmacy?
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.