Apozeal Pharmaceuticals Inc.
Form 483 issued April 9, 2019 · Levittown, Pennsylvania
- Inspection
- Mar 11 – Apr 9, 2019
- Investigators
- Christina K. Theodorou· Dandan Wang· Lisa B. Orr
- Observations
- 8
- Pages
- 11
- FEI number
- 3004536846
In short: On April 9, 2019, FDA issued a Form 483 with 8 observations to Apozeal Pharmaceuticals Inc. in Levittown, Pennsylvania (FEI 3004536846) after an inspection that ran Mar 11 – Apr 9, 2019. The investigators were Christina K. Theodorou, Dandan Wang and Lisa B. Orr. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 5 of 8 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Investigations of an unexplained discrepancy did not extend to other batches of the same drug product…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Christina K. Theodorou
19 documents · 2016–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmApozeal Pharmaceuticals Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Apozeal Pharmaceuticals Inc.?
FDA listed 8 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Apozeal Pharmaceuticals Inc.?
Christina K. Theodorou, Dandan Wang and Lisa B. Orr are named on this Form 483, for the inspection of Mar 11 – Apr 9, 2019. Each investigator has a profile showing what they cite most.
When was Apozeal Pharmaceuticals Inc. inspected by FDA?
The inspection ran Mar 11 – Apr 9, 2019, and the Form 483 is dated April 9, 2019.
How do I get the full Form 483 for Apozeal Pharmaceuticals Inc.?
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