Aurolife Pharma LLC
Form 483 issued February 12, 2020 · Dayton, New Jersey
- Inspection
- Jan 13 – Feb 12, 2020
- Investigators
- Emmanuel J. Ramos· Jogy George· Lata Mathew
- Observations
- 9
- Pages
- 19
- FEI number
- 3005796917
In short: On February 12, 2020, FDA issued a Form 483 with 9 observations to Aurolife Pharma LLC in Dayton, New Jersey (FEI 3005796917) after an inspection that ran Jan 13 – Feb 12, 2020. The investigators were Emmanuel J. Ramos, Jogy George, Lata Mathew and Unnee Ranjan. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.67 (2×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The control systems necessary to prevent contamination…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Emmanuel J. Ramos
9 documents · 2017–2021
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
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 211.67
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 quality system, facilities & equipment 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?
Emmanuel J. Ramos, Jogy George, Lata Mathew and Unnee Ranjan are named on this Form 483, for the inspection of Jan 13 – Feb 12, 2020. Each investigator has a profile showing what they cite most.
When was Aurolife Pharma LLC inspected by FDA?
The inspection ran Jan 13 – Feb 12, 2020, and the Form 483 is dated February 12, 2020.
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.