Pharmacy Creations
Form 483 issued August 5, 2022 · Ledgewood, New Jersey
- Inspection
- Jul 11 – Aug 5, 2022
- Investigators
- Amy N. Chen· Sena G. Dissmeyer· Tekalign Wondimu
- Observations
- 9
- Pages
- 8
- FEI number
- 3003348498
In short: On August 5, 2022, FDA issued a Form 483 with 9 observations to Pharmacy Creations in Ledgewood, New Jersey (FEI 3003348498) after an inspection that ran Jul 11 – Aug 5, 2022. The investigators were Amy N. Chen, Sena G. Dissmeyer and Tekalign Wondimu. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Observations span 2 systems, led by laboratory controls.
Most cited: FDCA 501(a)(2)(A) (7×)
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
The ISO 5 classified aseptic processing areas had visibly…
- 02FDCA 501(a)(2)(A)
Personnel did not disinfect and change gloves frequently…
- 03FDCA 501(a)(2)(A)
Materials or supplies were not disinfected prior to entering…
- 04FDCA 501(a)(2)(A)
The use of sporicidal agents in the cleanrooms and ISO 5 classified aseptic processing area was…
This inspection in context
Amy N. Chen
8 documents · 2022–2023
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Maryland.
The firmPharmacy Creations history
All 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmacy Creations?
FDA listed 9 observations on this Form 483, mostly about laboratory controls and production. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Pharmacy Creations?
Amy N. Chen, Sena G. Dissmeyer and Tekalign Wondimu are named on this Form 483, for the inspection of Jul 11 – Aug 5, 2022. Each investigator has a profile showing what they cite most.
When was Pharmacy Creations inspected by FDA?
The inspection ran Jul 11 – Aug 5, 2022, and the Form 483 is dated August 5, 2022.
How do I get the full Form 483 for Pharmacy Creations?
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.