Burklow Pharmacy, Inc.
Form 483 issued March 4, 2015 · Pace, Florida
- Inspection
- Mar 2 – Mar 4, 2015
- Investigator
- Michael H. Tollon
- Observations
- 3
- Pages
- 1
- FEI number
- 3005758901
In short: On March 4, 2015, FDA issued a Form 483 with 3 observations to Burklow Pharmacy, Inc. in Pace, Florida (FEI 3005758901) after an inspection that ran Mar 2 – Mar 4, 2015. The investigator was Michael H. Tollon. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
3 of 3 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Michael H. Tollon
12 documents · 2013–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Florida.
The firmBurklow Pharmacy, 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 211.165(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Burklow Pharmacy, Inc.?
FDA listed 3 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Burklow Pharmacy, Inc.?
Michael H. Tollon is named on this Form 483, for the inspection of Mar 2 – Mar 4, 2015. Each investigator has a profile showing what they cite most.
When was Burklow Pharmacy, Inc. inspected by FDA?
The inspection ran Mar 2 – Mar 4, 2015, and the Form 483 is dated March 4, 2015.
How do I get the full Form 483 for Burklow Pharmacy, 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.