Form 483 · FEI 1000526871
Form 483 issued March 10, 2020 · Morris Plains, New Jersey
- Inspection
- Mar 2 – Mar 10, 2020
- Investigators
- Andrea Siegel· Guerlain Ulysse· Wayne Seifert
- Observations
- 10
- Pages
- 9
- FEI number
- 1000526871
In short: On March 10, 2020, FDA issued a Form 483 with 10 observations to an FDA-inspected site in Morris Plains, New Jersey (FEI 1000526871) after an inspection that ran Mar 2 – Mar 10, 2020. The investigators were Andrea Siegel, Guerlain Ulysse, Wayne Seifert and Willie Wilson. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and production account for 8 of 10 observations.
Most cited: 21 CFR 211.68 (4×) · 211.194 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures and controls designed to prevent microbiological contamination of the drug substance intermediate and related…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Standard operating procedures are…
- 04
Appropriate controls are not exercised over computers or related…
This inspection in context
Andrea Siegel
2 documents · 2019–2020
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Maryland.
The firmSite 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
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, production and quality system. 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 an FDA-inspected site?
Andrea Siegel, Guerlain Ulysse, Wayne Seifert and Willie Wilson are named on this Form 483, for the inspection of Mar 2 – Mar 10, 2020. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Mar 2 – Mar 10, 2020, and the Form 483 is dated March 10, 2020.
How do I get the full Form 483 for an FDA-inspected site?
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.