CMC Enterprise Pharmacy
Form 483 issued March 22, 2020 · Charlotte, North Carolina
- Inspection
- Mar 18 – Mar 22, 2020
- Investigators
- Adam R. Cooke· Rachael L. Cook
- Observations
- 9
- Pages
- 6
- FEI number
- 3014539004
In short: On March 22, 2020, FDA issued a Form 483 with 9 observations to CMC Enterprise Pharmacy in Charlotte, North Carolina (FEI 3014539004) after an inspection that ran Mar 18 – Mar 22, 2020. The investigators were Adam R. Cooke and Rachael L. Cook. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 9 of 9 observations.
Most cited: 21 CFR 211.42 (4×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The ISO 5 classified aseptic processing areas had difficult to clean, particle-generating and visibly…
- 02
Your facility design allowed the influx of poor quality air into…
- 03
Your facility was designed and/or operated in a way that permits poor flow…
- 04
Materials or supplies were not disinfected prior to entering…
This inspection in context
Adam R. Cooke
11 documents · 2015–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in North Carolina.
The firmCMC Enterprise Pharmacy history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CMC Enterprise Pharmacy?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected CMC Enterprise Pharmacy?
Adam R. Cooke and Rachael L. Cook are named on this Form 483, for the inspection of Mar 18 – Mar 22, 2020. Each investigator has a profile showing what they cite most.
When was CMC Enterprise Pharmacy inspected by FDA?
The inspection ran Mar 18 – Mar 22, 2020, and the Form 483 is dated March 22, 2020.
How do I get the full Form 483 for CMC Enterprise 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.