Arnold Professional Pharmacy
Form 483 issued May 6, 2016 · Arnold, Maryland
- Inspection
- May 4 – May 6, 2016
- Investigators
- Jai P. Singh· Tajah L. Blackburn
- Observations
- 4
- Pages
- 2
- FEI number
- 3012283530
In short: On May 6, 2016, FDA issued a Form 483 with 4 observations to Arnold Professional Pharmacy in Arnold, Maryland (FEI 3012283530) after an inspection that ran May 4 – May 6, 2016. The investigators were Jai P. Singh and Tajah L. Blackburn. Most observations concern laboratory controls and facilities & equipment.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Testing and release of drug products for distribution do not include appropriate laboratory determination of satisfactory…
- 02
Records of the calibration checks of automatic, mechanical or electronic equipment, including computers or related…
- 03
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 04
Control procedures are not established which validate the performance of those manufacturing processes that may be…
This inspection in context
Jai P. Singh
2 documents · 2016–2020
Cites 211.165 (testing and release for distribution) more than any other section. Most of their documents are for sites in Maryland.
The firmArnold Professional Pharmacy history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Arnold Professional Pharmacy?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected Arnold Professional Pharmacy?
Jai P. Singh and Tajah L. Blackburn are named on this Form 483, for the inspection of May 4 – May 6, 2016. Each investigator has a profile showing what they cite most.
When was Arnold Professional Pharmacy inspected by FDA?
The inspection ran May 4 – May 6, 2016, and the Form 483 is dated May 6, 2016.
How do I get the full Form 483 for Arnold Professional 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.