Pharmasol Corporation
Form 483 issued July 16, 2015 · South Easton, Massachusetts
- Inspection
- Jul 7 – Jul 16, 2015
- Investigators
- Cassandra L. Abellard· Kim L. Thomas Cruse· Uttaniti Limchumroon
- Observations
- 12
- Pages
- 15
- FEI number
- 1250001
In short: On July 16, 2015, FDA issued a Form 483 with 12 observations to Pharmasol Corporation in South Easton, Massachusetts (FEI 1250001) after an inspection that ran Jul 7 – Jul 16, 2015. The investigators were Cassandra L. Abellard, Kim L. Thomas Cruse, Uttaniti Limchumroon, William Leonard and Yvonne Y. Wu. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Laboratory controls and quality system account for 9 of 12 observations.
Most cited: 21 CFR 211.194 (3×) · 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
The accuracy, specificity, and reproducibility of test methods…
- 03
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 04
Laboratory records are deficient in that they do not include a complete record of all…
This inspection in context
Cassandra L. Abellard
6 documents · 2015–2023
Cites 211.194 (laboratory records) more than any other section. Most of their documents are for sites in Puerto Rico.
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 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmasol Corporation?
FDA listed 12 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Pharmasol Corporation?
Cassandra L. Abellard, Kim L. Thomas Cruse, Uttaniti Limchumroon, William Leonard and Yvonne Y. Wu are named on this Form 483, for the inspection of Jul 7 – Jul 16, 2015. Each investigator has a profile showing what they cite most.
When was Pharmasol Corporation inspected by FDA?
The inspection ran Jul 7 – Jul 16, 2015, and the Form 483 is dated July 16, 2015.
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.