Keystone Rx LLC
Form 483 issued July 12, 2020 · Bensalem, Pennsylvania
- Inspection
- Jul 8 – Jul 12, 2020
- Investigators
- David A. Oluwo· Sena G. Dissmeyer
- Observations
- 1
- Pages
- 2
- FEI number
- 3015119302
In short: On July 12, 2020, FDA issued a Form 483 with 1 observation to Keystone Rx LLC in Bensalem, Pennsylvania (FEI 3015119302) after an inspection that ran Jul 8 – Jul 12, 2020. The investigators were David A. Oluwo and Sena G. Dissmeyer. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Non-microbial contamination was observed…
This inspection in context
David A. Oluwo
27 documents · 2017–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Maryland.
The firmKeystone Rx LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Keystone Rx LLC?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Keystone Rx LLC?
David A. Oluwo and Sena G. Dissmeyer are named on this Form 483, for the inspection of Jul 8 – Jul 12, 2020. Each investigator has a profile showing what they cite most.
When was Keystone Rx LLC inspected by FDA?
The inspection ran Jul 8 – Jul 12, 2020, and the Form 483 is dated July 12, 2020.
How do I get the full Form 483 for Keystone Rx 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.