The Compounding Pharmacy
Form 483 issued September 29, 2021 · Hickory, North Carolina
- Inspection
- Sep 20 – Sep 29, 2021
- Investigator
- Adam R. Cooke
- Observations
- 3
- Pages
- 3
- FEI number
- 3009127876
In short: On September 29, 2021, FDA issued a Form 483 with 3 observations to The Compounding Pharmacy in Hickory, North Carolina (FEI 3009127876) after an inspection that ran Sep 20 – Sep 29, 2021. The investigator was Adam R. Cooke. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
3 of 3 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (2×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your facility design allowed the influx of poor quality air into…
- 02
The classified aseptic processing areas had difficult to clean and/or visibly…
- 03
Non-depyrogenated equipment was used…
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 firmThe Compounding Pharmacy history
All 3 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 The Compounding Pharmacy?
FDA listed 3 observations 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 The Compounding Pharmacy?
Adam R. Cooke is named on this Form 483, for the inspection of Sep 20 – Sep 29, 2021. Each investigator has a profile showing what they cite most.
When was The Compounding Pharmacy inspected by FDA?
The inspection ran Sep 20 – Sep 29, 2021, and the Form 483 is dated September 29, 2021.
How do I get the full Form 483 for The Compounding 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.