Central Admixture Pharmacy Services, Inc.
Form 483 issued August 22, 2018 · Allentown, Pennsylvania
- Inspection
- Jul 30 – Aug 22, 2018
- Investigators
- Gayle S. Lawson· Zhongren Wu
- Observations
- 8
- Pages
- 9
- FEI number
- 3009590582
In short: On August 22, 2018, FDA issued a Form 483 with 8 observations to Central Admixture Pharmacy Services, Inc. in Allentown, Pennsylvania (FEI 3009590582) after an inspection that ran Jul 30 – Aug 22, 2018. The investigators were Gayle S. Lawson and Zhongren Wu. 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 5 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Gayle S. Lawson
10 documents · 2015–2019
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Pennsylvania.
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 211.42(c)(10)
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 8 observations on this Form 483, mostly about facilities & equipment, production and quality system. 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 Central Admixture Pharmacy Services, Inc.?
Gayle S. Lawson and Zhongren Wu are named on this Form 483, for the inspection of Jul 30 – Aug 22, 2018. Each investigator has a profile showing what they cite most.
When was Central Admixture Pharmacy Services, Inc. inspected by FDA?
The inspection ran Jul 30 – Aug 22, 2018, and the Form 483 is dated August 22, 2018.
How do I get the full Form 483 for Central Admixture Pharmacy Services, Inc.?
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