PHARMARON MANUFACTURING SERVICES (US) LLC
Form 483 issued January 23, 2020 · Coventry, Rhode Island
- Inspection
- Jan 13 – Jan 23, 2020
- Observations
- 1
- Pages
- 1
- FEI number
- 1211201
In short: On January 23, 2020, FDA issued a Form 483 with 1 observation to PHARMARON MANUFACTURING SERVICES (US) LLC in Coventry, Rhode Island (FEI 1211201) after an inspection that ran Jan 13 – Jan 23, 2020. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your Quality Control Unit fai led to follow written procedures for the proper release of production…
This inspection in context
Questions about this 483
What did FDA find at PHARMARON MANUFACTURING SERVICES (US) LLC?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
When was PHARMARON MANUFACTURING SERVICES (US) LLC inspected by FDA?
The inspection ran Jan 13 – Jan 23, 2020, and the Form 483 is dated January 23, 2020.
How do I get the full Form 483 for PHARMARON MANUFACTURING SERVICES (US) 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.