Central Admixture Pharmacy Services, Inc.
Form 483 issued February 11, 2015 · Allentown, Pennsylvania
- Inspection
- Feb 3 – Feb 11, 2015
- Investigators
- Junho Pak· Kendra L. Brooks· Vlada Matusovsky
- Observations
- 6
- Pages
- 4
- FEI number
- 3009590582
In short: On February 11, 2015, FDA issued a Form 483 with 6 observations to Central Admixture Pharmacy Services, Inc. in Allentown, Pennsylvania (FEI 3009590582) after an inspection that ran Feb 3 – Feb 11, 2015. The investigators were Junho Pak, Kendra L. Brooks and Vlada Matusovsky. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
4 of 6 observations on this 483 concern production.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Each batch of drug product purporting to be sterile is not laboratory tested to determine…
- 04
There is a failure to thoroughly review the failure of a batch or any of its…
This inspection in context
Junho Pak
28 documents · 2012–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmCentral Admixture Pharmacy Services, Inc. history
All 8 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
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 6 observations on this Form 483, mostly about production, laboratory controls and quality system. 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.?
Junho Pak, Kendra L. Brooks and Vlada Matusovsky are named on this Form 483, for the inspection of Feb 3 – Feb 11, 2015. Each investigator has a profile showing what they cite most.
When was Central Admixture Pharmacy Services, Inc. inspected by FDA?
The inspection ran Feb 3 – Feb 11, 2015, and the Form 483 is dated February 11, 2015.
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.