Central Admixture Pharmacy Services Inc
Form 483 issued May 4, 2022 · Cranbeny Township, Pennsylvania
- Inspection
- Apr 26 – May 4, 2022
- Investigators
- Amy N. Chen· Elaine E. Gilfillan· Jazmine N. Brown
- Observations
- 4
- Pages
- 4
- FEI number
- 3011755753
In short: On May 4, 2022, FDA issued a Form 483 with 4 observations to Central Admixture Pharmacy Services Inc in Cranbeny Township, Pennsylvania (FEI 3011755753) after an inspection that ran Apr 26 – May 4, 2022. The investigators were Amy N. Chen, Elaine E. Gilfillan and Jazmine N. Brown. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
3 of 4 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (3×) · 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
Personnel conducted aseptic manipulations and placed equipment/supplies in an area that blocked the movement of first…
- 02
Disinfecting agents and cleaning wipes used in the ISO S classified aseptic processing…
- 03
The facility is designed and operated in a way that may permit the influx of lesser…
- 04
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities…
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 firmCentral Admixture Pharmacy Services Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Central Admixture Pharmacy Services Inc?
FDA listed 4 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Central Admixture Pharmacy Services Inc?
Amy N. Chen, Elaine E. Gilfillan and Jazmine N. Brown are named on this Form 483, for the inspection of Apr 26 – May 4, 2022. Each investigator has a profile showing what they cite most.
When was Central Admixture Pharmacy Services Inc inspected by FDA?
The inspection ran Apr 26 – May 4, 2022, and the Form 483 is dated May 4, 2022.
How do I get the full Form 483 for Central Admixture Pharmacy Services Inc?
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.