Pharmasol Corporation
Form 483 issued June 14, 2021 · South Easton, Massachusetts
- Inspection
- Aug 31, 2020 – Jun 14, 2021
- Investigators
- Daniel L. Zheng· Lori M. Newman
- Observations
- 7
- Pages
- 10
- FEI number
- 1250001
In short: On June 14, 2021, FDA issued a Form 483 with 7 observations to Pharmasol Corporation in South Easton, Massachusetts (FEI 1250001) after an inspection that ran Aug 31, 2020 – Jun 14, 2021. The investigators were Daniel L. Zheng and Lori M. Newman. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Quality system and facilities & equipment account for 6 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
The responsibilities and procedures applicable to the quality control unit are not in writing and fully…
- 03
Routine calibration and checking of automatic and mechanical equipment is not performed according to a written…
- 04
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Daniel L. Zheng
24 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
The firmPharmasol Corporation history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmasol Corporation?
FDA listed 7 observations on this Form 483, mostly about quality system, facilities & equipment and production. 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 Pharmasol Corporation?
Daniel L. Zheng and Lori M. Newman are named on this Form 483, for the inspection of Aug 31, 2020 – Jun 14, 2021. Each investigator has a profile showing what they cite most.
When was Pharmasol Corporation inspected by FDA?
The inspection ran Aug 31, 2020 – Jun 14, 2021, and the Form 483 is dated June 14, 2021.
How do I get the full Form 483 for Pharmasol Corporation?
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.