ImprimisRx Pharmacy, LLC
Form 483 issued August 1, 2016 · Folcroft, Pennsylvania
- Inspection
- Jun 28 – Aug 1, 2016
- Investigators
- Gayle S. Lawson· Lisa B. Orr
- Observations
- 8
- Pages
- 9
- FEI number
- 3012124155
In short: On August 1, 2016, FDA issued a Form 483 with 8 observations to ImprimisRx Pharmacy, LLC in Folcroft, Pennsylvania (FEI 3012124155) after an inspection that ran Jun 28 – Aug 1, 2016. The investigators were Gayle S. Lawson and Lisa B. Orr. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
Adequate lab facilities for testing and approval or rejection of components, drug product containers and drug…
- 02
An adequate number of batches of each drug product are not tested nor are records of…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
- 04
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the…
This inspection in context
Gayle S. Lawson
10 documents · 2015–2019
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmImprimisRx Pharmacy, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ImprimisRx Pharmacy, LLC?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, production and quality system. The opening words of each observation are shown on this page.
Who inspected ImprimisRx Pharmacy, LLC?
Gayle S. Lawson and Lisa B. Orr are named on this Form 483, for the inspection of Jun 28 – Aug 1, 2016. Each investigator has a profile showing what they cite most.
When was ImprimisRx Pharmacy, LLC inspected by FDA?
The inspection ran Jun 28 – Aug 1, 2016, and the Form 483 is dated August 1, 2016.
How do I get the full Form 483 for ImprimisRx Pharmacy, LLC?
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.