Keystone Pharmacy
Form 483 issued November 22, 2017 · Grand Rapids, Michigan
- Inspection
- Oct 18 – Oct 30, 2017
- Investigators
- Charles L. Zhou· Constantin Y. Philopoulos
- Observations
- 1
- Pages
- 3
- FEI number
- 3004488698
In short: On November 22, 2017, FDA issued a Form 483 with 1 observation to Keystone Pharmacy in Grand Rapids, Michigan (FEI 3004488698) after an inspection that ran Oct 18 – Oct 30, 2017. The investigators were Charles L. Zhou and Constantin Y. Philopoulos. 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×) · 211.42 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You produced highly potent drngs without providing adequate segregation and cleaning of…
This inspection in context
Charles L. Zhou
11 documents · 2016–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Michigan.
The firmKeystone Pharmacy 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 Pharmacy?
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 Pharmacy?
Charles L. Zhou and Constantin Y. Philopoulos are named on this Form 483, for the inspection of Oct 18 – Oct 30, 2017. Each investigator has a profile showing what they cite most.
When was Keystone Pharmacy inspected by FDA?
The inspection ran Oct 18 – Oct 30, 2017, and the Form 483 is dated November 22, 2017.
How do I get the full Form 483 for Keystone 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.