Aarkish Pharmaceuticals NJ Inc
Form 483 issued August 18, 2022 · Fairfield, New Jersey
- Inspection
- Aug 8 – Aug 18, 2022
- Investigators
- Jessica S. Estriplet· Junho Pak· Karen A. Briggs
- Observations
- 9
- Pages
- 12
- FEI number
- 3017532195
In short: On August 18, 2022, FDA issued a Form 483 with 9 observations to Aarkish Pharmaceuticals NJ Inc in Fairfield, New Jersey (FEI 3017532195) after an inspection that ran Aug 8 – Aug 18, 2022. The investigators were Jessica S. Estriplet, Junho Pak and Karen A. Briggs. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
6 of 9 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (3×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Batch production and control records for each batch of drug product produced do not include an…
- 02
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 03
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 04
Failure to maintain a backup file of data entered into the…
This inspection in context
Jessica S. Estriplet
18 documents · 2021–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New Jersey.
The firmAarkish Pharmaceuticals NJ Inc 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 Aarkish Pharmaceuticals NJ Inc?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, production and materials. 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 Aarkish Pharmaceuticals NJ Inc?
Jessica S. Estriplet, Junho Pak and Karen A. Briggs are named on this Form 483, for the inspection of Aug 8 – Aug 18, 2022. Each investigator has a profile showing what they cite most.
When was Aarkish Pharmaceuticals NJ Inc inspected by FDA?
The inspection ran Aug 8 – Aug 18, 2022, and the Form 483 is dated August 18, 2022.
How do I get the full Form 483 for Aarkish Pharmaceuticals NJ Inc?
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