Aurolife Pharma LLC
Form 483 issued December 7, 2021 · Dayton, New Jersey
- Inspection
- Oct 25 – Dec 7, 2021
- Investigators
- David A. Oluwo· Jay B. Shah· Ko U. Min
- Observations
- 9
- Pages
- 16
- FEI number
- 3005796917
In short: On December 7, 2021, FDA issued a Form 483 with 9 observations to Aurolife Pharma LLC in Dayton, New Jersey (FEI 3005796917) after an inspection that ran Oct 25 – Dec 7, 2021. The investigators were David A. Oluwo, Jay B. Shah and Ko U. Min. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and quality system account for 7 of 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate standards and test procedures…
This inspection in context
David A. Oluwo
27 documents · 2017–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Maryland.
The firmAurolife Pharma LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Aurolife Pharma LLC?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Aurolife Pharma LLC?
David A. Oluwo, Jay B. Shah and Ko U. Min are named on this Form 483, for the inspection of Oct 25 – Dec 7, 2021. Each investigator has a profile showing what they cite most.
When was Aurolife Pharma LLC inspected by FDA?
The inspection ran Oct 25 – Dec 7, 2021, and the Form 483 is dated December 7, 2021.
How do I get the full Form 483 for Aurolife Pharma 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.