Apertus Pharmaceuticals, LLC
Form 483 issued January 16, 2020 · Ballwin, Missouri
- Inspection
- Jan 13 – Jan 16, 2020
- Investigators
- Ana P. Sandee· Michele Perry Williams· Robert J. Ham
- Observations
- 5
- Pages
- 4
- FEI number
- 3010401502
In short: On January 16, 2020, FDA issued a Form 483 with 5 observations to Apertus Pharmaceuticals, LLC in Ballwin, Missouri (FEI 3010401502) after an inspection that ran Jan 13 – Jan 16, 2020. The investigators were Ana P. Sandee, Michele Perry Williams and Robert J. Ham. Most observations concern facilities & equipment and packaging & labeling; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and packaging & labeling account for 3 of 5 observations.
Most cited: 21 CFR 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 02
The results of the examination of the packaged and labeled products were not documented in the…
- 03
The in-process control procedures were deficient in that it did not include…
- 04
Written procedures are not established for evaluations conducted at least (6)(4)J§ to review records associated with…
This inspection in context
Ana P. Sandee
6 documents · 2019–2020
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Missouri.
The firmApertus Pharmaceuticals, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Apertus Pharmaceuticals, LLC?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, packaging & labeling and production. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Apertus Pharmaceuticals, LLC?
Ana P. Sandee, Michele Perry Williams and Robert J. Ham are named on this Form 483, for the inspection of Jan 13 – Jan 16, 2020. Each investigator has a profile showing what they cite most.
When was Apertus Pharmaceuticals, LLC inspected by FDA?
The inspection ran Jan 13 – Jan 16, 2020, and the Form 483 is dated January 16, 2020.
How do I get the full Form 483 for Apertus Pharmaceuticals, LLC?
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.